Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) (NCT NCT04857034)
NCT ID: NCT04857034
Last Updated: 2025-09-10
Results Overview
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
From first dose to Week 16 (approximately 16 weeks)
Results posted on
2025-09-10
Participant Flow
74 participants randomized and 73 treated in the placebo controlled period. 18 participants who received placebo in the placebo controlled period were randomized into 2 separate treatment arms during active treatment period.
Participant milestones
| Measure |
Placebo-Controlled Period: Treatment 1
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
Placebo
|
Active-Treatment Period: Treatment 1
Deucravacitinib 3mg
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|---|
|
Placebo-Controlled Period
STARTED
|
25
|
25
|
24
|
0
|
0
|
|
Placebo-Controlled Period
COMPLETED
|
21
|
20
|
22
|
0
|
0
|
|
Placebo-Controlled Period
NOT COMPLETED
|
4
|
5
|
2
|
0
|
0
|
|
Active Treatment Period
STARTED
|
16
|
20
|
0
|
9
|
9
|
|
Active Treatment Period
COMPLETED
|
11
|
9
|
0
|
5
|
6
|
|
Active Treatment Period
NOT COMPLETED
|
5
|
11
|
0
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo-Controlled Period: Treatment 1
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
Placebo
|
Active-Treatment Period: Treatment 1
Deucravacitinib 3mg
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|---|
|
Placebo-Controlled Period
Request to discontinue
|
2
|
2
|
0
|
0
|
0
|
|
Placebo-Controlled Period
withdrew consent
|
1
|
1
|
2
|
0
|
0
|
|
Placebo-Controlled Period
Pregnancy
|
1
|
1
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Ongoing study period
|
0
|
1
|
0
|
0
|
0
|
|
Active Treatment Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
|
Active Treatment Period
request to discontinue
|
0
|
1
|
0
|
1
|
0
|
|
Active Treatment Period
administrative reason by sponsor
|
1
|
5
|
0
|
2
|
2
|
|
Active Treatment Period
other reasons
|
1
|
1
|
0
|
0
|
1
|
|
Active Treatment Period
Ongoing Study Period
|
2
|
4
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Baseline characteristics by cohort
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=25 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=24 Participants
Placebo
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
47.3 Years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
42.8 Years
STANDARD_DEVIATION 12.16 • n=7 Participants
|
46.2 Years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
45.4 Years
STANDARD_DEVIATION 13.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose to Week 16 (approximately 16 weeks)Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=23 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Percentage Change From Baseline in CLASI Activity Score at Week 16
|
-48.56 Percentage change from baseline
Standard Deviation 44.684
|
-48.93 Percentage change from baseline
Standard Deviation 33.302
|
-27.31 Percentage change from baseline
Standard Deviation 29.716
|
—
|
SECONDARY outcome
Timeframe: From first dose to Week 16 (approximately 16 weeks)Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=23 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).
|
60.0 Percentage of participants
|
54.2 Percentage of participants
|
21.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From first dose to Week 16 (approximately 16 weeks)Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=23 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.
|
60.0 Percentage of participants
|
66.7 Percentage of participants
|
39.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From first dose to Week 16 (approximately 16 weeks)Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=23 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Mean Change From Baseline in CLASI-A Score.
|
-9.8 Score on a Scale
Standard Deviation 12.69
|
-7.5 Score on a Scale
Standard Deviation 5.92
|
-4.3 Score on a Scale
Standard Deviation 5.54
|
—
|
SECONDARY outcome
Timeframe: From first dose to Week 16 (approximately 16 weeks)Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 Complete Response (CR) on CLASI-A defined as a score of "0".
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=23 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".
|
12.0 Percentage of Participants
|
4.2 Percentage of Participants
|
0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the Placebo Controlled Period
Number of participants with safety related events in the placebo controlled period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=24 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Safety Related Events in the Placebo Controlled Period
TEAE
|
17 Participants
|
19 Participants
|
12 Participants
|
—
|
|
Number of Participants With Safety Related Events in the Placebo Controlled Period
Treatment-related TEAEs
|
11 Participants
|
11 Participants
|
3 Participants
|
—
|
|
Number of Participants With Safety Related Events in the Placebo Controlled Period
Treatment related Serious TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Safety Related Events in the Placebo Controlled Period
Serious TEAE
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the active treatment period
Number of participants with safety related events in the active treatment period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=16 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=20 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=9 Participants
Placebo
|
Active-Treatment Period: Treatment 2
n=9 Participants
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Safety Related Events in the Active Treatment Period
TEAEs
|
11 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Safety Related Events in the Active Treatment Period
Treatment related TEAEs
|
5 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Safety Related Events in the Active Treatment Period
Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Safety Related Events in the Active Treatment Period
Treatment related serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the Placebo Controlled Period
Number of participants with clinically significant laboratory abnormalities in the placebo controlled period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=24 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period
Creatinine Kinase ≥ 2.5x ULN
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period
Hemoglobin < 9 g/dL (90g/L)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the active treatment period
Number of participants with clinically significant laboratory abnormalities in the active treatment period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=16 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=20 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=9 Participants
Placebo
|
Active-Treatment Period: Treatment 2
n=9 Participants
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period
ALT > 3xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period
AST > 3xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period
Creatinine Kinase ≥ 2.5x ULN
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period
Hemoglobin < 9 g/dL (90g/L)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the Placebo Controlled Period
Number of participants with clinically significant vital sign abnormalities in the placebo controlled period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=24 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent to end of safety follow up period (Approximately 60 weeks)Population: All Treated Population in the active treatment period
Number of participants with clinically significant vital sign abnormalities in the active treatment period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=16 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=20 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=9 Participants
Placebo
|
Active-Treatment Period: Treatment 2
n=9 Participants
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signing informed consent to end of active treatment period (Approximately 56 weeks)Population: All Treated Population in the Placebo Controlled Period
Number of participants with clinically significant ECG abnormalities in the placebo controlled period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=25 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=24 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=24 Participants
Placebo
|
Active-Treatment Period: Treatment 2
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent to end of active treatment period (Approximately 56 weeks)Population: All Treated Population in the active treatment period
Number of participants with clinically significant ECG abnormalities in the active treatment period
Outcome measures
| Measure |
Placebo-Controlled Period: Treatment 1
n=16 Participants
Deucravactinib 3mg
|
Placebo-Controlled Period: Treatment 2
n=20 Participants
Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
|
Placebo-Controlled Period: Placebo
n=9 Participants
Placebo
|
Active-Treatment Period: Treatment 2
n=9 Participants
Deucravacitinib 6mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo-Controlled Period - DEUC 3 mg BID
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo-Controlled Period - DEUC 6 mg BID
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo-Controlled Period - Placebo BID
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Active Treatment Period - DEUC 3 mg BID
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Active Treatment Period - DEUC 6 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active Treatment Period - Placebo-DEUC 3 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Treatment Period - Placebo-DEUC 6 mg BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Controlled Period - DEUC 3 mg BID
n=25 participants at risk
Deucravactinib 3mg in the Placebo controlled period
|
Placebo-Controlled Period - DEUC 6 mg BID
n=24 participants at risk
Deucravactinib 6 mg in the Placebo controlled period
|
Placebo-Controlled Period - Placebo BID
n=24 participants at risk
Placebo in the Placebo controlled period
|
Active Treatment Period - DEUC 3 mg BID
n=16 participants at risk
Deucravactinib 3mg in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period
|
Active Treatment Period - DEUC 6 mg BID
n=20 participants at risk
Deucravactinib 6mg in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period
|
Active Treatment Period - Placebo-DEUC 3 mg BID
n=9 participants at risk
Placebo in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period
|
Active Treatment Period - Placebo-DEUC 6 mg BID
n=9 participants at risk
Placebo in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral herpes
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Abortion induced incomplete
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Placebo-Controlled Period - DEUC 3 mg BID
n=25 participants at risk
Deucravactinib 3mg in the Placebo controlled period
|
Placebo-Controlled Period - DEUC 6 mg BID
n=24 participants at risk
Deucravactinib 6 mg in the Placebo controlled period
|
Placebo-Controlled Period - Placebo BID
n=24 participants at risk
Placebo in the Placebo controlled period
|
Active Treatment Period - DEUC 3 mg BID
n=16 participants at risk
Deucravactinib 3mg in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period
|
Active Treatment Period - DEUC 6 mg BID
n=20 participants at risk
Deucravactinib 6mg in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period
|
Active Treatment Period - Placebo-DEUC 3 mg BID
n=9 participants at risk
Placebo in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period
|
Active Treatment Period - Placebo-DEUC 6 mg BID
n=9 participants at risk
Placebo in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pustule
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
2/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Peripheral swelling
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
31.2%
5/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Folliculitis
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
2/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pharyngitis
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
2/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
2/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.0%
2/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.8%
5/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Aphthous ulcer
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Mucous stools
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mass
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Acute sinusitis
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Ear infection
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Erythrasma
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Groin abscess
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral herpes
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pertussis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Schistosomiasis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tooth infection
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Viral infection
|
4.0%
1/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
1/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Disturbance in attention
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Nerve degeneration
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Sciatica
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Micturition urgency
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
1/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/25 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/16 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/20 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • AEs/SAEs are collected from the time of signing the consent until post treatment follow up period of 28 days, approximately 13 months.
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
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