Trial Outcomes & Findings for Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) (NCT NCT03881059)
NCT ID: NCT03881059
Last Updated: 2022-02-15
Results Overview
A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
16 weeks after first dose
Results posted on
2022-02-15
Participant Flow
203 participants were randomized and treated.
Participant milestones
| Measure |
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Treatment Period - Part A
STARTED
|
66
|
70
|
67
|
|
Treatment Period - Part A
COMPLETED
|
58
|
63
|
59
|
|
Treatment Period - Part A
NOT COMPLETED
|
8
|
7
|
8
|
|
Treatment Period - Part B
STARTED
|
55
|
60
|
58
|
|
Treatment Period - Part B
Participants Maintaining Same Treatment as in Part A
|
0
|
13
|
16
|
|
Treatment Period - Part B
Participants Treated With Ustekinumab in Part B
|
55
|
47
|
42
|
|
Treatment Period - Part B
COMPLETED
|
47
|
54
|
47
|
|
Treatment Period - Part B
NOT COMPLETED
|
8
|
6
|
11
|
Reasons for withdrawal
| Measure |
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Treatment Period - Part A
Adverse Event
|
1
|
3
|
4
|
|
Treatment Period - Part A
Randomized by mistake with study treatment
|
0
|
1
|
1
|
|
Treatment Period - Part A
Withdrawal by Subject
|
5
|
2
|
3
|
|
Treatment Period - Part A
Other reasons
|
2
|
1
|
0
|
|
Treatment Period - Part B
Adverse Event
|
0
|
0
|
3
|
|
Treatment Period - Part B
Death
|
0
|
1
|
1
|
|
Treatment Period - Part B
Lack of Efficacy
|
1
|
1
|
0
|
|
Treatment Period - Part B
Lost to Follow-up
|
1
|
1
|
0
|
|
Treatment Period - Part B
Site terminated by sponsor
|
1
|
0
|
3
|
|
Treatment Period - Part B
Withdrawal by Subject
|
1
|
0
|
1
|
|
Treatment Period - Part B
Other reasons
|
4
|
3
|
3
|
Baseline Characteristics
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
Baseline characteristics by cohort
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.5 Years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
50.5 Years
STANDARD_DEVIATION 13.69 • n=7 Participants
|
50.5 Years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
49.8 Years
STANDARD_DEVIATION 13.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
|
31.8 Percent of Participants
Interval 20.6 to 43.1
|
52.9 Percent of Participants
Interval 41.2 to 64.6
|
62.7 Percent of Participants
Interval 51.1 to 74.3
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants
The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person has experienced during the past week in 8 domains of daily living activities. Each activity category consists of 2 to 3 questions (total of 20 questions). For reach question the level of activity is scored from 0 to 3, with 0 representing "no difficulty" and 3 as "unable to do". Any activity that requires assistance from another individual or an assistive device adjusts to a minimum score of 2. For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.11 Score on a scale
Standard Error 0.066
|
-0.37 Score on a scale
Standard Error 0.065
|
-0.39 Score on a scale
Standard Error 0.067
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with at least 3% Body Surface Area (BSA) involvement at baseline
The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI 75 response rate represents the percentage of participants who experienced at least a 75% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
Outcome measures
| Measure |
Placebo
n=54 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=59 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=52 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response
|
20.4 Percent of Participants
Interval 9.6 to 31.1
|
42.4 Percent of Participants
Interval 29.8 to 55.0
|
59.6 Percent of Participants
Interval 46.3 to 73.0
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants
The SF-36 is a patient-reported outcome measure, which includes 36 items in a Likert-type format to measure the following 8 health dimensions over the past week: 1) limitations in physical activities, such as bathing or dressing 2) limitations in social activities because of physical or emotional problems 3) limitations in usual role activities because of physical health problems 4) bodily pain 5) general mental health (psychological distress and well-being) 6) limitations in usual role activities because of emotional problems 7) vitality (energy and fatigue) and 8) general health perceptions. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
|
2.3 Score on a scale
Standard Error 0.97
|
5.6 Score on a scale
Standard Error 0.94
|
5.8 Score on a scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A participant is considered an ACR 50 responder if the following three conditions are met: 1) ≥ 50% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 50% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 50% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16
|
10.6 Percent of Participants
Interval 3.2 to 18.0
|
24.3 Percent of Participants
Interval 14.2 to 34.3
|
32.8 Percent of Participants
Interval 21.6 to 44.1
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A participant is considered an ACR 70 responder if the following three conditions are met: 1) ≥ 70% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 70% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 70% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16
|
1.5 Percent of Participants
Interval 0.0 to 4.5
|
14.3 Percent of Participants
Interval 6.1 to 22.5
|
19.4 Percent of Participants
Interval 9.9 to 28.9
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • \< 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • \> 5.1: High disease activity. Only participants with a score \< 3.2 are considered to have achieved low disease activity.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
|
22.7 Percent of Participants
Interval 12.6 to 32.8
|
37.1 Percent of Participants
Interval 25.8 to 48.5
|
43.3 Percent of Participants
Interval 31.4 to 55.1
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • \< 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • \> 5.1: High disease activity. Only participants with a score \< 2.6 are considered to have achieved remission.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
|
6.1 Percent of Participants
Interval 0.3 to 11.8
|
24.3 Percent of Participants
Interval 14.2 to 34.3
|
25.4 Percent of Participants
Interval 15.0 to 35.8
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants
A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • \< 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • \> 5.1: High disease activity. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.7 Score on a scale
Standard Error 0.15
|
-1.7 Score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with dactylitis count ≥ 1 at baseline
The number of digits in hands and feet with dactylitis (Tender + Non-Tender) was counted and change from baseline at week 16 was assessed. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=25 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=33 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=27 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in Dactylitis Count
|
-1.8 Digits with dactylitis
Standard Error 0.40
|
-2.0 Digits with dactylitis
Standard Error 0.38
|
-2.5 Digits with dactylitis
Standard Error 0.38
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with LDI score \> 0 at baseline
The Leeds Dactylitis Index (LDI) Basic is a quantitative measurement of dactylitis in the 20 digits using a dactylometer. The circumference of the affected and contralateral digits, and tenderness of the affected digits are measured to generate a total score. For each dactylitic digit, the final score is defined as: \[{(A/B) - 1}\*100\]\*C, where A is circumference of involved digit, B is circumference of the opposite, unaffected, digit or reference, and C is tenderness (0 or 1). The total score is determined by summing the relative score of all digits. A higher score indicates worse dactylitis. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=24 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=30 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=23 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score
|
-28.3 Score on a scale
Standard Error 8.87
|
-41.8 Score on a scale
Standard Error 8.35
|
-44.5 Score on a scale
Standard Error 8.90
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with dactylitis count (tender digits only) ≥ 1 at baseline
Dactylitis resolution (tender digits only) is defined as a dactylitis count of 0 in participants with dactylitis count ≥ 1 at baseline
Outcome measures
| Measure |
Placebo
n=25 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=30 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=24 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Dactylitis Resolution
|
60.0 Percent of Participants
Interval 40.8 to 79.2
|
76.7 Percent of Participants
Interval 61.5 to 91.8
|
79.2 Percent of Participants
Interval 62.9 to 95.4
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with LEI score ≥ 1 at baseline
The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=31 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=39 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=26 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)
|
-1.2 Score on a scale
Standard Error 0.27
|
-1.5 Score on a scale
Standard Error 0.25
|
-1.7 Score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with SPARCC enthesitis index score ≥ 1 at baseline
The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=34 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=43 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=34 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
|
-1.2 Score on a scale
Standard Error 0.54
|
-2.9 Score on a scale
Standard Error 0.48
|
-3.1 Score on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with LEI score ≥ 1 at baseline
The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Enthesitis resolution is defined as s LEI score of 0, in subjects with LEI ≥ 1 at baseline
Outcome measures
| Measure |
Placebo
n=31 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=39 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=26 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)
|
22.6 Percent of Participants
Interval 7.9 to 37.3
|
51.3 Percent of Participants
Interval 35.6 to 67.0
|
50.0 Percent of Participants
Interval 30.8 to 69.2
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with SPARCC enthesitis index score ≥ 1 at baseline
The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Enthesitis resolution defined as a SPARCC enthesitis index score of 0, in subjects with SPARCC ≥ 1 at baseline.
Outcome measures
| Measure |
Placebo
n=34 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=43 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=34 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
|
17.6 Percent of Participants
Interval 4.8 to 30.5
|
51.2 Percent of Participants
Interval 36.2 to 66.1
|
41.2 Percent of Participants
Interval 24.6 to 57.7
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with PGA-F score ≥ 3 at baseline
In participants with psoriasis fingernail involvement, the PGA-F score is used to evaluate the overall condition of the fingernails in terms of disease severity. The assessment is performed by the investigator, who rates the fingernail condition on a 5-point scale based on the higher of the nail bed/nail matrix score. Scores are 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
Outcome measures
| Measure |
Placebo
n=12 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=14 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=20 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1
|
0 Percent of Participants
Interval 0.0 to 0.0
|
21.4 Percent of Participants
Interval 0.0 to 42.9
|
50.0 Percent of Participants
Interval 28.1 to 71.9
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
A Minimal Disease Activity (MDA) responder is defined as a participant fulfilling 5 of the following 7 outcomes: • Tender joint count ≤ 1 • Swollen joint count ≤ 1 • Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% • Subject Global Assessment of pain ≤ 15 • Subject Global Assessment of disease activity ≤ 20 • Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5 • Tender entheseal points ≤ 1
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
|
7.6 Percent of Participants
Interval 1.2 to 14.0
|
22.9 Percent of Participants
Interval 13.0 to 32.7
|
23.9 Percent of Participants
Interval 13.7 to 34.1
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
PASDAS is a composite measure calculated from the Physician Global Assessment of psoriatic arthritis, the Subject Global Assessment of disease activity, the Short Form Health Survey-36 Item (SF-36) Physical Component Summary (PCS), the swollen joint count, the tender joint count, the Leeds Enthesitis Index (LEI), the Leeds Dactylitis Index (LDI) (Basic), and the the levels of high-sensitivity C-reactive Protein (hsCRP). Each item contributes differently to the final score, which ranges from 0 to 10 (higher scores represent a higher level of disease activity). Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=63 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=66 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
|
-1.1 Score on a scale
Standard Error 0.21
|
-2.0 Score on a scale
Standard Error 0.20
|
-2.1 Score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants
DAPSA is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count 68, swollen joint count 66, Subject Global Assessment of disease activity, Subject Global Assessment of pain, and the levels of C-reactive Protein (CRP). Final scores are interpreted as follows: - ≤4 = Remission (REM) - \> 4 and ≤ 28 = moderate disease activity (MDA) - \>28 = high disease activity (HDA). Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)
|
-13.3 Score on a scale
Standard Error 2.20
|
-23.2 Score on a scale
Standard Error 2.16
|
-25.6 Score on a scale
Standard Error 2.23
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
PsARC consists of 4 measurements: tender/painful joint count, swollen joint count, Physician Global Assessment of psoriatic arthritis, and Subject Global Assessment of pain ≤ 15. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
|
54.5 Percent of Participants
Interval 42.5 to 66.6
|
75.7 Percent of Participants
Interval 65.7 to 85.8
|
74.6 Percent of Participants
Interval 64.2 to 85.0
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with evidence of psoriatic arthritis spondylitis at baseline
In participants with baseline evidence of Psoriatic Arthritis Spondylitis, symptoms are evaluated using the BASDAI, which consists of a 0 to 100 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: • Fatigue (medical) • Spinal pain • Joint pain and swelling • Areas of localized tenderness • Morning stiffness duration • Morning stiffness severity A higher count indicates worse disease. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=15 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=19 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=16 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
-1.7 Score on a scale
Standard Error 0.55
|
-2.0 Score on a scale
Standard Error 0.48
|
-2.2 Score on a scale
Standard Error 0.57
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants
The SF-36 is a patient-reported outcome measure, which includes 36 items in a Likert-type format to measure the following 8 health dimensions over the past week: 1) limitations in physical activities, such as bathing or dressing 2) limitations in social activities because of physical or emotional problems 3) limitations in usual role activities because of physical health problems 4) bodily pain 5) general mental health (psychological distress and well-being) 6) limitations in usual role activities because of emotional problems 7) vitality (energy and fatigue) and 8) general health perceptions. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
|
0.7 Score on a scale
Standard Error 1.00
|
3.6 Score on a scale
Standard Error 0.97
|
3.5 Score on a scale
Standard Error 1.01
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants
PsAID is a 12-item self-report that measures psoriatic arthritis symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale, and each item contributes differently to the final score. Weighted scores for each item are summed and divided by 20 to generate the final score, ranging from 0 to 10 (higher values indicate worse health). Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
|
-1.0 Score on a scale
Standard Error 0.26
|
-2.1 Score on a scale
Standard Error 0.26
|
-2.3 Score on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
The FACIT-Fatigue instrument is a questionnaire used to evaluate a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The questionnaire is composed of 13 questions (Short Form 13a) and each question is scored from 1 to 5. The final score results from the sum of the scores of the 13 questions, and ranges from 13 (most desirable outcome) to 65 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=65 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=67 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=65 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
|
2.8 Score on a scale
Standard Error 1.17
|
5.6 Score on a scale
Standard Error 1.16
|
7.2 Score on a scale
Standard Error 1.18
|
SECONDARY outcome
Timeframe: From baseline (day of the first dose) to 16 weeks after first dosePopulation: All treated participants
The Work Limitation Questionnaire (WLQ) is a 25-item self-report that measures the on-the-job impact of chronic health conditions and treatment over the past 2 weeks. It focuses on assessing limitations while performing specific job demands from the following 4 domains: 1) Time management: difficulty with handling time and scheduling demands (5 items) 2) Physical demands: ability to perform job tasks that involve bodily strength, movement, endurance, coordination, and flexibility (6 items) 3) Mental-interpersonal demands: cognitively demanding tasks and on-the-job social interactions (9 items) 4) Output demands: concerns reduced work productivity (5 items). Final score ranges from 0 (limited none of the time) to 100 (limited all of the time). The score can be used to calculate a percent of lost work productivity due to a particular disease state. Adjusted change represents a change from baseline based on statistical model.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score
|
-1.2 Score on a scale
Standard Error 0.69
|
-1.9 Score on a scale
Standard Error 0.67
|
-2.7 Score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants
The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 questions (total of 20 questions). For reach question the level of activity is scored from 0 ("no difficulty") to 3 ("unable to do"). For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). A HAQ-DI 0.35 responder is defined as a participant with an improvement from baseline in HAQ-DI score of at least 0.35.
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response
|
15.2 Percent of Participants
Interval 6.5 to 23.8
|
38.6 Percent of Participants
Interval 27.2 to 50.0
|
40.3 Percent of Participants
Interval 28.6 to 52.0
|
SECONDARY outcome
Timeframe: 16 weeks after first dosePopulation: All treated participants with at least 3% Body Surface Area (BSA) involvement at baseline
The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI 90 response rate represents the percentage of participants who experienced at least a 90% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
Outcome measures
| Measure |
Placebo
n=54 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=59 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=52 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response
|
9.3 Percent of Participants
Interval 1.5 to 17.0
|
20.3 Percent of Participants
Interval 10.1 to 30.6
|
34.6 Percent of Participants
Interval 21.7 to 47.5
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=66 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=70 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=67 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Results
PR Interval, Aggregate
|
3.9 msec
Standard Deviation 16.40
|
3.2 msec
Standard Deviation 17.83
|
-2.9 msec
Standard Deviation 37.09
|
|
Change From Baseline in Electrocardiogram (ECG) Results
QRS Duration, Aggregate
|
-0.5 msec
Standard Deviation 9.07
|
3.9 msec
Standard Deviation 11.58
|
-1.1 msec
Standard Deviation 13.55
|
|
Change From Baseline in Electrocardiogram (ECG) Results
QT Interval, Aggregate
|
1.4 msec
Standard Deviation 27.47
|
2.7 msec
Standard Deviation 28.56
|
1.5 msec
Standard Deviation 26.81
|
|
Change From Baseline in Electrocardiogram (ECG) Results
QTcB Interval, Aggregate
|
2.8 msec
Standard Deviation 41.79
|
-6.7 msec
Standard Deviation 24.46
|
0.4 msec
Standard Deviation 20.34
|
|
Change From Baseline in Electrocardiogram (ECG) Results
QTcF Interval, Aggregate
|
-0.6 msec
Standard Deviation 29.83
|
2.4 msec
Standard Deviation 29.62
|
4.4 msec
Standard Deviation 22.96
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=57 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=63 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=59 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate
|
-0.7 beats/min
Standard Deviation 8.28
|
-1.0 beats/min
Standard Deviation 9.84
|
0.0 beats/min
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=59 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=64 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Diastolic Blood Pressure
|
1.1 mmHg
Standard Deviation 8.67
|
-0.9 mmHg
Standard Deviation 6.10
|
-1.7 mmHg
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=59 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=64 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Heart Rate
|
0.7 beats/min
Standard Deviation 9.40
|
-2.5 beats/min
Standard Deviation 9.02
|
0.8 beats/min
Standard Deviation 8.56
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=59 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=64 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Respiratory Rate
|
0.0 breaths/min
Standard Deviation 1.88
|
-0.2 breaths/min
Standard Deviation 1.46
|
0.2 breaths/min
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=59 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=64 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Systolic Blood Pressure
|
1.6 mmHg
Standard Deviation 11.05
|
-0.6 mmHg
Standard Deviation 10.95
|
-1.5 mmHg
Standard Deviation 11.44
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=59 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=64 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Temperature
|
-0.05 Celsius degree (C)
Standard Deviation 0.307
|
-0.07 Celsius degree (C)
Standard Deviation 0.364
|
-0.06 Celsius degree (C)
Standard Deviation 0.323
|
SECONDARY outcome
Timeframe: From baseline (day of first dose) to 16 weeks after first dosePopulation: All treated participants with available measurements
Outcome measures
| Measure |
Placebo
n=58 Participants
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg
n=63 Participants
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
BMS-986165 12 mg
n=60 Participants
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
|
|---|---|---|---|
|
Change From Baseline in Vital Signs - Weight
|
-0.24 Kg
Standard Deviation 3.690
|
0.18 Kg
Standard Deviation 2.646
|
0.43 Kg
Standard Deviation 2.823
|
Adverse Events
Only Part A:Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Only Part A:BMS-986165 6 mg QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Only Part A:BMS-986165 12 mg QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: Placebo + Part B: Ustekinumab SQ
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
BMS-986165 6 mg in Part A and Part B
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ
Serious events: 3 serious events
Other events: 30 other events
Deaths: 1 deaths
BMS-986165 12 mg in Part A and Part B
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ
Serious events: 4 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Only Part A:Placebo
n=11 participants at risk
In Part A, Placebo matching BMS-986165.
|
Only Part A:BMS-986165 6 mg QD
n=10 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks.
|
Only Part A:BMS-986165 12 mg QD
n=9 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks.
|
Part A: Placebo + Part B: Ustekinumab SQ
n=55 participants at risk
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg in Part A and Part B
n=13 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg
|
Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ
n=47 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ.
|
BMS-986165 12 mg in Part A and Part B
n=16 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg
|
Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ
n=42 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
General disorders
Death
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Vascular disorders
Deep vein thrombosis
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
Other adverse events
| Measure |
Only Part A:Placebo
n=11 participants at risk
In Part A, Placebo matching BMS-986165.
|
Only Part A:BMS-986165 6 mg QD
n=10 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks.
|
Only Part A:BMS-986165 12 mg QD
n=9 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks.
|
Part A: Placebo + Part B: Ustekinumab SQ
n=55 participants at risk
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
|
BMS-986165 6 mg in Part A and Part B
n=13 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg
|
Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ
n=47 participants at risk
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ.
|
BMS-986165 12 mg in Part A and Part B
n=16 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg
|
Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ
n=42 participants at risk
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Large intestine polyp
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Retching
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Subileus
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
General disorders
Injection site discomfort
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
General disorders
Peripheral swelling
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
3.6%
2/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.4%
3/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Furuncle
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Oral infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
15.4%
2/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.5%
2/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.1%
3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
5.5%
3/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Viral infection
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
5.5%
3/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Blood pressure increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.1%
3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Hepatic enzyme increased
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Platelet count increased
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Transaminases increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.4%
3/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesenteric neoplasm
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.1%
3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Eye disorders
Cataract
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.5%
2/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
5.5%
3/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
General disorders
Asthenia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
General disorders
Pyrexia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
18.8%
3/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Hepatobiliary disorders
Cholelithiasis
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
COVID-19
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.9%
5/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Ear infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Gingivitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.7%
7/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.8%
6/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.5%
2/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
26.2%
11/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.3%
4/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
15.4%
2/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.4%
3/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
3.6%
2/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.5%
2/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
15.4%
2/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Body temperature increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Investigations
Weight increased
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.9%
6/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
15.4%
2/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
12.8%
6/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
9.5%
4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
15.4%
2/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.4%
3/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
3.6%
2/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.4%
3/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Gastrointestinal disorders
Ileal ulcer
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.4%
1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
1.8%
1/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.1%
3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.3%
2/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
4.8%
2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
18.2%
2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
3.6%
2/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
7.7%
1/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
10.0%
1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
11.1%
1/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
2.1%
1/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
6.2%
1/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
|
Vascular disorders
Post thrombotic syndrome
|
9.1%
1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/9 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/55 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/13 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/47 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/16 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
0.00%
0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
All participants receiving treatment either only in Part A or in Part A + Part B
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER