Trial Outcomes & Findings for A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer (NCT NCT05609370)
NCT ID: NCT05609370
Last Updated: 2026-07-23
Results Overview
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
Results posted on
2026-07-23
Participant Flow
The study began in January 2023 and was conducted in 3 countries. The study consisted of Phase 1b and Phase 2. Phase 1b was completed as planned. On 20 December 2024, the sponsor decided to close enrollment in Phase 2 before achieving the planned sample size. Participants who continued to benefit from the study drugs were permitted to continue treatment in an Extended treatment Period which is currently ongoing.
Participants in Phase 1b were assigned to cohorts of increasing dose levels of alcestobart sequentially. In Phase 2, PD-L1-positive participants were randomized in a 2:1:2 ratio to 1 of 3 treatment arms stratified by liver metastases (absent vs. present) and PD-L1-negative participants were randomized in a 1:1 ratio to 1 of 2 treatment arms.
Participant milestones
| Measure |
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose+ Tislelizumab + Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
13
|
6
|
18
|
9
|
16
|
22
|
23
|
|
Overall Study
Treated
|
6
|
13
|
6
|
18
|
9
|
14
|
22
|
22
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
6
|
18
|
9
|
16
|
22
|
23
|
Reasons for withdrawal
| Measure |
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose+ Tislelizumab + Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
3
|
1
|
4
|
|
Overall Study
Study terminated by sponsor
|
3
|
2
|
2
|
6
|
5
|
5
|
8
|
5
|
|
Overall Study
Death
|
1
|
3
|
1
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Continuing in Extended Treatment Period
|
1
|
6
|
1
|
10
|
2
|
8
|
10
|
12
|
Baseline Characteristics
A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=13 Participants
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 Participants
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
n=18 Participants
PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
n=9 Participants
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=16 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=22 Participants
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
n=23 Participants
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 7.66 • n=9 Participants
|
57.8 years
STANDARD_DEVIATION 13.27 • n=27 Participants
|
53.7 years
STANDARD_DEVIATION 11.62 • n=267 Participants
|
54.6 years
STANDARD_DEVIATION 11.16 • n=265 Participants
|
63.0 years
STANDARD_DEVIATION 9.75 • n=568 Participants
|
56.3 years
STANDARD_DEVIATION 14.18 • n=22 Participants
|
61.1 years
STANDARD_DEVIATION 11.24 • n=23 Participants
|
58.1 years
STANDARD_DEVIATION 10.42 • n=22 Participants
|
58.0 years
STANDARD_DEVIATION 11.51 • n=178 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
7 Participants
n=23 Participants
|
11 Participants
n=22 Participants
|
53 Participants
n=178 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
12 Participants
n=22 Participants
|
60 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
9 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
22 Participants
n=23 Participants
|
22 Participants
n=22 Participants
|
105 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
14 Participants
n=23 Participants
|
15 Participants
n=22 Participants
|
69 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
5 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
32 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
5 Participants
n=178 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
5 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
29 Participants
n=178 Participants
|
|
Region of Enrollment
China
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
14 Participants
n=23 Participants
|
16 Participants
n=22 Participants
|
66 Participants
n=178 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
18 Participants
n=178 Participants
|
|
Liver Metastases: Yes/No
Yes
|
5 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
13 Participants
n=22 Participants
|
14 Participants
n=23 Participants
|
18 Participants
n=22 Participants
|
85 Participants
n=178 Participants
|
|
Liver Metastases: Yes/No
No
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
8 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
28 Participants
n=178 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.Population: Phase 1b safety analysis population: All participants who have received ≥ 1 dose of any component of study treatment.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose- * resulted in death, * was life threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, * was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=13 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 Participants
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment emergent adverse event
|
13 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Serious adverse event
|
8 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)Population: ITT Analysis Set of Arms A and C for PD-L1-positive population.
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=16 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=18 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
|
4.4 months
Interval 2.1 to
Values could not be estimated due to an insufficient number of events
|
NA months
Interval 3.5 to
Values could not be estimated due to an insufficient number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)Population: ITT Analysis Set of Arms A and C for PD-L1-positive population.
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=16 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=18 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)Population: ITT Analysis Set of Arms A and C for PD-L1-positive population. Only patients with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis.
DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=1 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
|
—
|
NA months
Values could not be estimated due to an insufficient number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)Population: ITT Analysis Set of Arms D and E for PD-L1 negative population.
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=23 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=22 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
|
10.4 months
Interval 4.1 to
Values could not be estimated due to an insufficient number of events
|
6.5 months
Interval 3.9 to
Values could not be estimated due to an insufficient number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))Population: ITT Analysis Set of Arms D and E for PD-L1 negative population.
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=23 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=22 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0.0 Percentage of participants
Interval 0.0 to 15.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)Population: ITT Analysis Set of Arms D and E for PD-L1 negative population.
DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=1 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
|
NA months
Values could not be estimated due to an insufficient number of events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 monthsPopulation: Phase 2 safety analysis population: All participants who have received ≥ 1 dose of any component of study treatment.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose- * resulted in death, * was life threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, * was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=9 Participants
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=18 Participants
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=14 Participants
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
|
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
n=22 Participants
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
n=22 Participants
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Treatment-emergent AEs and SAEs
Treatment Emergent adverse event
|
9 Participants
|
17 Participants
|
13 Participants
|
22 Participants
|
22 Participants
|
|
Phase 2: Number of Participants With Treatment-emergent AEs and SAEs
Serious adverse event
|
1 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
Adverse Events
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Serious events: 8 serious events
Other events: 13 other events
Deaths: 3 deaths
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab+ Bevacizumab+ Fluoropyrimidine
Serious events: 7 serious events
Other events: 21 other events
Deaths: 2 deaths
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
Serious events: 4 serious events
Other events: 22 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 participants at risk
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=13 participants at risk
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 participants at risk
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
n=18 participants at risk
PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
n=9 participants at risk
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=14 participants at risk
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab+ Bevacizumab+ Fluoropyrimidine
n=22 participants at risk
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
n=22 participants at risk
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Hepatobiliary disorders
Gallbladder fistula
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Cerebral infarction
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
Other adverse events
| Measure |
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 participants at risk
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=13 participants at risk
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
n=6 participants at risk
Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.
The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine
n=18 participants at risk
PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
n=9 participants at risk
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
n=14 participants at risk
PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab+ Bevacizumab+ Fluoropyrimidine
n=22 participants at risk
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
n=22 participants at risk
PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.
The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
50.0%
3/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
4/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Catheter site erythema
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Catheter site pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
30.8%
4/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
28.6%
4/14 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.7%
5/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Generalised oedema
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Influenza like illness
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Localised oedema
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.7%
5/22 • Number of events 9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Myocardial injury
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Myocardial oedema
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
66.7%
4/6 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
38.5%
5/13 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
50.0%
3/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
27.8%
5/18 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Entropion
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Episcleritis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Retinopathy
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Trichiasis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
21.4%
3/14 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
30.8%
4/13 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
21.4%
3/14 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
27.3%
6/22 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Dental abfraction
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
38.5%
5/13 • Number of events 8 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
27.8%
5/18 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
21.4%
3/14 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
30.8%
4/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 11 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
21.4%
3/14 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.7%
5/22 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Prealbumin decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Troponin T increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Urine bilirubin increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Urobilinogen faeces increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
30.8%
4/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Weight increased
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
50.0%
3/6 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
4/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
4/18 • Number of events 9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
4/18 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Painful ejaculation
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Reproductive system and breast disorders
Vulval leukoplakia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.0%
3/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
83.3%
5/6 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
3/9 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.7%
5/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.7%
5/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
23.1%
3/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Pyrexia
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Swelling face
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Temperature intolerance
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
General disorders and administration site conditions
Thirst
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Periodontitis
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
18.2%
4/22 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
4/6 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
50.0%
3/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Albumin urine present
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Anti-thyroid antibody increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Apolipoprotein B increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
50.0%
3/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Bile acids increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Bilirubin conjugated increased
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
33.3%
2/6 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
3/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
21.4%
3/14 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 7 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood bilirubin unconjugated increased
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
14.3%
2/14 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood cholinesterase decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood cholinesterase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood corticotrophin increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
4/18 • Number of events 5 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
9.1%
2/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood immunoglobulin E increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 4 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
13.6%
3/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
2/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
22.2%
2/9 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.7%
1/13 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Electrocardiogram high voltage
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
7.1%
1/14 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
2/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Gastrointestinal stoma output increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Interleukin level increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
5.6%
1/18 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/9 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
4.5%
1/22 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
15.4%
2/13 • Number of events 3 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
16.7%
1/6 • Number of events 2 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/13 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/6 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/18 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
11.1%
1/9 • Number of events 1 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/14 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
0.00%
0/22 • Mortality was collected up to the end of the main part of the study, maximum time on study was 22.9 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 16.2 months.
All-cause mortality is reported for all enrolled (Phase 1b) and randomized (Phase 2) participants. Adverse events are reported for the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER