Trial Outcomes & Findings for Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis (NCT NCT04186871)
NCT ID: NCT04186871
Last Updated: 2024-01-16
Results Overview
mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
Week 24
Results posted on
2024-01-16
Participant Flow
Participants were enrolled concurrently for the RA, SLE, and pSS sub-studies.
Participant milestones
| Measure |
SLE- Placebo
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Placebo
Participants with primary Sjögren's syndrome (pSS) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Branebrutinib
Participants with primary Sjögren's syndrome (pSS) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
RA- Placebo
Participants with rheumatoid arthritis (RA) receive placebo once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
RA- Branebrutinib
Participants with rheumatoid arthritis (RA) receive branebrutinib 9mg once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
4
|
10
|
21
|
64
|
|
Overall Study
Double Blind Period
|
5
|
15
|
4
|
10
|
21
|
64
|
|
Overall Study
Open Label Period
|
0
|
0
|
0
|
0
|
20
|
61
|
|
Overall Study
COMPLETED
|
3
|
11
|
4
|
9
|
20
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
1
|
1
|
6
|
Reasons for withdrawal
| Measure |
SLE- Placebo
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Placebo
Participants with primary Sjögren's syndrome (pSS) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Branebrutinib
Participants with primary Sjögren's syndrome (pSS) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
RA- Placebo
Participants with rheumatoid arthritis (RA) receive placebo once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
RA- Branebrutinib
Participants with rheumatoid arthritis (RA) receive branebrutinib 9mg once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Study terminated by sponsor
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Other reasons
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
SLE- Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=15 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Placebo
n=4 Participants
Participants with primary Sjögren's syndrome (pSS) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Branebrutinib
n=10 Participants
Participants with primary Sjögren's syndrome (pSS) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
RA- Placebo
n=21 Participants
Participants with rheumatoid arthritis (RA) receive placebo once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
RA- Branebrutinib
n=64 Participants
Participants with rheumatoid arthritis (RA) receive branebrutinib 9mg once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
47.8 Years
STANDARD_DEVIATION 4.19 • n=5 Participants
|
46.6 Years
STANDARD_DEVIATION 9.28 • n=4 Participants
|
46.0 Years
STANDARD_DEVIATION 12.95 • n=21 Participants
|
50.1 Years
STANDARD_DEVIATION 11.62 • n=8 Participants
|
48.2 Years
STANDARD_DEVIATION 11.68 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
97 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese · Asian - Non-Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese · Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese · White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
101 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese · Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All treated participants with a baseline mCLASI activity score ≥ 10 at Week 24 (Prespecified for participants in the SLE cohort only).
mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index
Outcome measures
| Measure |
SLE- Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=15 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE
|
60.0 Percentage of participants
Interval 17.1 to 100.0
|
33.3 Percentage of participants
Interval 9.5 to 57.2
|
PRIMARY outcome
Timeframe: Week 24Population: All Treated Participants (Prespecified for participants in the pSS cohort only).
Composite response is defined as the percent of participants with at least 3 of the following at Week 24: * Decrease of ≥ 1 point or 15% from baseline in the ESSPRI Total Score * Decrease of ≥ 3 points from baseline in ESSDAI score * Decrease of ≥ 25% from baseline in ocular staining score, or if normal score at baseline no change to abnormal * Increase of ≥ 25% from baseline in stimulated salivary flow * Improvement in one or more serological markers (rheumatoid factor (RF), immunoglobulin G protein (IgG), complement C3 or C4, cryoglobulin).
Outcome measures
| Measure |
SLE- Placebo
n=4 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=10 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
The Percent of Participants With Composite Response at Week 24 - pSS
|
25 Percent of Participants
Interval 0.0 to 67.4
|
10 Percent of Participants
Interval 0.0 to 28.6
|
PRIMARY outcome
Timeframe: Week 12Population: All Treated Participants (Prespecified for participants in the RA cohort only).
ACR50 response is defined as both improvement of 50% in the number of tender and swollen joints and a 50% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=21 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=64 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA
|
33.3 Percent of Participants
Interval 13.2 to 53.5
|
18.8 Percent of Participants
Interval 9.2 to 28.3
|
SECONDARY outcome
Timeframe: Week 24Population: All Treated Participants with week 24 measurements (Prespecified for participants in the SLE cohort only).
The SLEDAI-2K is a global index providing a total score of overall disease activity ranging from 0 to 105, with higher scores representing more active disease. The SLEDAI index includes 24 items divided into 9 organ systems: neurological, musculoskeletal, renal, mucocutaneous, general, heart, respiratory, vascular, and hematological. Each item is scored based on the severity of the symptom or finding, with higher scores indicating more severe disease activity. The weighted scores for each item range from 0 to 8. To calculate the SLEDAI-2K score, the scores for each of the 24 items are added together. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=4 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=11 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Change From Baseline in SLEDAI-2K Score at Week 24 - SLE
|
-7.0 Change in "score on a scale"
Standard Deviation 5.29
|
-7.0 Change in "score on a scale"
Standard Deviation 6.54
|
SECONDARY outcome
Timeframe: Week 24Population: All Treated Participants (Prespecified for participants in the SLE cohort only).
BILAG-based composite lupus assessment (BICLA) response is defined as: 1. At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry 2. No new BILAG A or more than one new BILAG B scores 3. No worsening of total SLEDAI score from baseline 4. No significant deterioration (\< 10%) in PGA and 5. No treatment failure (initiation of nonprotocol treatment). BILAG scores: A (severe disease), B (moderate), C (mild), or D (no activity). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=15 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Percent of Participants With BICLA Response at Week 24 - SLE
|
20.0 Percent of participants
Interval 0.5 to 71.6
|
33.3 Percent of participants
Interval 11.8 to 61.6
|
SECONDARY outcome
Timeframe: Week 12Population: All Treated Participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).
The Disease Activity Score-28-C-Reactive Protein (DAS28CRP) is a composite outcome assessment that measures: 1) How many joints in the hands, wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28, 2) CRP in the blood to measure the degree of inflammation, and 3) SGA of disease activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission 2.6 - 3.2: Low disease activity 3.2 - 5.1: Moderate disease activity \> 5.1: High disease activity A negative change from baseline in DAS28-CRP indicates an improvement. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=19 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=58 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Change From Baseline in DAS28-CRP at Week 12 - RA
|
-1.615 Score on a scale
Standard Deviation 1.19545
|
-1.542 Score on a scale
Standard Deviation 1.0790
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).
The Disease Activity Score Erythrocyte Sedimentation Rate - DAS28ESR is a composite outcome assessment that measures: 1. How many joints in the hands, wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28 2. ESR in the blood to measure the degree of inflammation 3. SGA of disease activity DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-ESR score, which correlates with the extent of disease activity: \< 2.6: Disease remission 2.6 - 3.2: Low disease activity 3.2 - 5.1: Moderate disease activity \> 5.1: High disease activity A negative change from baseline in DAS28-ESR indicates an improvement. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=20 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=58 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Change From Baseline in DAS28-ESR at Week 12 - RA
|
-1.758 Score on a scale
Standard Deviation 1.1932
|
-1.670 Score on a scale
Standard Deviation 1.1487
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).
The Simplified Disease Activity Index (SDAI) is the sum of the tender joint score (range 0 to 28), the swollen joint score (range 0 to 28), the subject global assessment (SGA) of disease activity (range 0 to 10 in increments of 0.5), the PGA of disease activity (range 0 to 10 in increments of 0.5), and C-reactive protein (CRP) test result. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. A SDAI score ranges from 0 (disease remission) to 86 (high disease activity).
Outcome measures
| Measure |
SLE- Placebo
n=19 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=58 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Change From Baseline in SDAI at Week 12- RA
|
-19.430 Score on a scale
Standard Deviation 12.5890
|
-18.303 Score on a scale
Standard Deviation 11.5793
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).
The Clinical Disease Activity Index (CDAI) is the sum of the tender joint score (range 0 to 28), the swollen joint score (range 0 to 28), the SGA of disease activity (range 0 to 10 in increments of 0.5), and the PGA of disease activity (range 0 to 10 in increments of 0.5). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. A CDAI score ranges from 0 to 76. The interpretation of CDAI is as follows: 0.0 - 2.8: Disease remission 2.9 - 10.0: Low disease activity (LDA) 10.1 - 22.0: Moderate disease activity 22.1 - 76.0: High disease activity
Outcome measures
| Measure |
SLE- Placebo
n=20 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=58 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Change From Baseline in CDAI at Week 12 - RA
|
-19.4 Score on a scale
Standard Deviation 12.07
|
-18.0 Score on a scale
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: Week 12Population: All Treated Participants (Prespecified for participants in the RA cohort only).
ACR20 defined as both improvement of 20% in the number of tender and swollen joints and a 20% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=21 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=64 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Percent of Participants With ACR20 Response Compared to Baseline at Week 12 - RA
|
61.9 Percent of Participants
Interval 41.1 to 82.7
|
57.8 Percent of Participants
Interval 45.7 to 69.9
|
SECONDARY outcome
Timeframe: Week 12Population: All Treated Participants (Prespecified for participants in the RA cohort only).
ACR70 is defined as both improvement of 70% in the number of tender and swollen joints and a 70% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Outcome measures
| Measure |
SLE- Placebo
n=21 Participants
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=64 Participants
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
|---|---|---|
|
Percent of Participants With ACR70 Response Compared to Baseline at Week 12 - RA
|
14.3 Percent of Participants
Interval 0.0 to 29.3
|
7.8 Percent of Participants
Interval 1.2 to 14.4
|
Adverse Events
SLE- Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SLE- Branebrutinib
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
pSS- Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
pSS- Branebrutinib
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
RA- Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RA- Branebrutinib
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
RA Abatacept
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SLE- Placebo
n=5 participants at risk
Participants with systemic lupus erythematosus (SLE) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
SLE- Branebrutinib
n=15 participants at risk
Participants with systemic lupus erythematosus (SLE) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Placebo
n=4 participants at risk
Participants with primary Sjögren's syndrome (pSS) receive placebo once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
pSS- Branebrutinib
n=10 participants at risk
Participants with primary Sjögren's syndrome (pSS) receive branebrutinib 9mg once daily (QD) during a 24-week double-blind placebo-controlled treatment period.
|
RA- Placebo
n=21 participants at risk
Participants with rheumatoid arthritis (RA) receive placebo once daily (QD) during a 12-week double-blind placebo-controlled treatment period, followed by an additional 12 weeks of treatment with open-label abatacept.
|
RA- Branebrutinib
n=64 participants at risk
Participants with rheumatoid arthritis (RA) receive branebrutinib 9mg once daily (QD) during a 12-week double-blind placebo-controlled treatment period.
|
RA Abatacept
n=81 participants at risk
Participants with rheumatoid arthritis (RA) receive 12 weeks of treatment with open-label abatacept after the 12-week double-blind placebo-controlled treatment period.
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|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
General disorders
Asthenia
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
General disorders
Discomfort
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.2%
1/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.2%
1/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
9.5%
2/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
7.8%
5/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
13.3%
2/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
13.3%
2/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
75.0%
3/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
20.0%
2/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
4.8%
1/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.2%
1/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
4.8%
1/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
3.1%
2/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
20.0%
3/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.2%
1/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Face injury
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
20.0%
2/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
4.8%
1/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Investigations
Gastric pH decreased
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
4.8%
1/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
20.0%
1/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
25.0%
1/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
4.8%
1/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.2%
1/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
9.5%
2/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Stress
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
20.0%
2/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
1.6%
1/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
6.7%
1/15 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/4 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
10.0%
1/10 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/21 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/64 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
0.00%
0/81 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 32 weeks) SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 weeks)
TEAEs are defined as AEs that occur after the participant received first dose of study treatment or if a preexisting condition worsens in severity or becomes serious after receiving the first dose of study treatment up to 30 days after the last dose of study treatment.
|
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