Trial Outcomes & Findings for Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001) (NCT NCT02761694)
NCT ID: NCT02761694
Last Updated: 2023-05-06
Results Overview
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with study-drug treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
78 participants
Primary outcome timeframe
Up to approximately 120 weeks
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Part 1: Vevorisertib 5 mg QD
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg QD
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
1
|
3
|
3
|
3
|
33
|
8
|
5
|
5
|
3
|
6
|
|
Overall Study
Treated
|
4
|
4
|
1
|
3
|
3
|
3
|
32
|
8
|
5
|
5
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
3
|
3
|
3
|
33
|
8
|
5
|
5
|
3
|
6
|
Reasons for withdrawal
| Measure |
Part 1: Vevorisertib 5 mg QD
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg QD
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
1
|
1
|
4
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
4
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Other
|
4
|
4
|
1
|
2
|
3
|
3
|
18
|
8
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)
Baseline characteristics by cohort
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg QD
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=33 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
4 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
71 Participants
n=7 Participants
|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
57.0 Years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
65.0 Years
STANDARD_DEVIATION NA • n=206 Participants
|
62.0 Years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
58.3 Years
STANDARD_DEVIATION 11.6 • n=31 Participants
|
53.0 Years
STANDARD_DEVIATION 20.2 • n=30 Participants
|
58.6 Years
STANDARD_DEVIATION 11.9 • n=3 Participants
|
59.0 Years
STANDARD_DEVIATION 8.4 • n=6 Participants
|
57.2 Years
STANDARD_DEVIATION 19.7 • n=114 Participants
|
59.8 Years
STANDARD_DEVIATION 11.3
|
52.3 Years
STANDARD_DEVIATION 7.6 • n=19 Participants
|
65.8 Years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
59.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
2 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
56 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
3 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
22 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
5 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
74 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 120 weeksPopulation: All participants who received at least 1 dose of study treatment.
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with study-drug treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=32 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
32 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 116 weeksPopulation: All participants who received at least 1 dose of study treatment.
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with study-drug treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=32 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.Population: All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess Cmax at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.
Cmax was defined as the maximum plasma drug concentration. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. Cmax is reported as geometric mean with a percent coefficient of variation.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=2 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=3 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=28 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Vevorisertib
Cycle 1 Day 1
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric Mean (percent geometric coefficient of variation) were not calculable because levels were below the limit of quantification (BLQ).
|
4.820 ng/mL
Geometric Coefficient of Variation 80.1
|
15.3 ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
51.39 ng/mL
Geometric Coefficient of Variation 68.1
|
22.73 ng/mL
Geometric Coefficient of Variation 5.9
|
59.79 ng/mL
Geometric Coefficient of Variation 7.6
|
98.75 ng/mL
Geometric Coefficient of Variation 88.2
|
122.6 ng/mL
Geometric Coefficient of Variation 107.1
|
29.13 ng/mL
Geometric Coefficient of Variation 245.6
|
49.11 ng/mL
Geometric Coefficient of Variation 67.0
|
91.7 ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
166.7 ng/mL
Geometric Coefficient of Variation 101.7
|
|
Maximum Plasma Concentration (Cmax) of Vevorisertib
Cycle 1 Day 22
|
4.154 ng/mL
Geometric Coefficient of Variation 45.3
|
12.82 ng/mL
Geometric Coefficient of Variation 71.1
|
7.79 ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
65.40 ng/mL
Geometric Coefficient of Variation 61.5
|
19.49 ng/mL
Geometric Coefficient of Variation 96.5
|
55.15 ng/mL
Geometric Coefficient of Variation 76.7
|
225.1 ng/mL
Geometric Coefficient of Variation 80.0
|
207.7 ng/mL
Geometric Coefficient of Variation 80.6
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Vevorisertib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
186.8 ng/mL
Geometric Coefficient of Variation 47.3
|
—
|
78.36 ng/mL
Geometric Coefficient of Variation 216.8
|
79.52 ng/mL
Geometric Coefficient of Variation 69.6
|
62.59 ng/mL
Geometric Coefficient of Variation 140.1
|
138.2 ng/mL
Geometric Coefficient of Variation 48.4
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.Population: All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess AUC0-24 at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.
AUC0-24hrs was defined as area under the concentration-time curve from time 0 to 24 hours after dose administration. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. AUC0-24 is reported as geometric mean with a percent coefficient of variation.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=2 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=2 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=28 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From 0-24 Hours (AUC0-24 Hours) of Vevorisertib
Cycle 1 Day1
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Geometric Mean (percent geometric coefficient of variation) were not calculable because levels were below the limit of quantification (BLQ).
|
12.27 hours*ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
42.2 hours*ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
244.1 hours*ng/mL
Geometric Coefficient of Variation 113.3
|
128.6 hours*ng/mL
Geometric Coefficient of Variation 52.4
|
287.5 hours*ng/mL
Geometric Coefficient of Variation 4.5
|
667.6 hours*ng/mL
Geometric Coefficient of Variation 84.6
|
786.1 hours*ng/mL
Geometric Coefficient of Variation 117.7
|
391.1 hours*ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
649.6 hours*ng/mL
Geometric Coefficient of Variation 41.7
|
449 hours*ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
1115 hours*ng/mL
Geometric Coefficient of Variation 73.5
|
|
Area Under the Curve From 0-24 Hours (AUC0-24 Hours) of Vevorisertib
Cycle 1 Day 22
|
—
|
67.89 hours*ng/mL
Geometric Coefficient of Variation 197.1
|
78.5 hours*ng/mL
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
501.8 hours*ng/mL
Geometric Coefficient of Variation 35.5
|
181.2 hours*ng/mL
Geometric Coefficient of Variation 59.0
|
543.8 hours*ng/mL
Geometric Coefficient of Variation 78.2
|
1832 hours*ng/mL
Geometric Coefficient of Variation 68.5
|
1786 hours*ng/mL
Geometric Coefficient of Variation 82.4
|
—
|
—
|
—
|
—
|
|
Area Under the Curve From 0-24 Hours (AUC0-24 Hours) of Vevorisertib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2013 hours*ng/mL
Geometric Coefficient of Variation 66.4
|
—
|
837.2 hours*ng/mL
Geometric Coefficient of Variation 200.6
|
1280 hours*ng/mL
Geometric Coefficient of Variation 39.1
|
750.7 hours*ng/mL
Geometric Coefficient of Variation 67.0
|
1948 hours*ng/mL
Geometric Coefficient of Variation 49.7
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: predose, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.Population: All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess t1/2 at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.
t1/2 was defined as the terminal elimination half-life of drug. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. t1/2 is reported as geometric mean with a percent coefficient of variation.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=2 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=2 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=2 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=25 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=7 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=2 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t½) of Vevorisertib
Cycle 1 Day 1
|
NA hours
Geometric Coefficient of Variation NA
Geometric Mean (percent geometric coefficient of variation) were not calculable because levels were below the limit of quantification (BLQ).
|
—
|
3.68 hours
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
15.43 hours
Geometric Coefficient of Variation 104.2
|
8.257 hours
Geometric Coefficient of Variation 102.7
|
15.94 hours
Geometric Coefficient of Variation 19.3
|
12.39 hours
Geometric Coefficient of Variation 37.7
|
7.437 hours
Geometric Coefficient of Variation 69.0
|
8.920 hours
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
8.909 hours
Geometric Coefficient of Variation 16.3
|
9.48 hours
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
9.176 hours
Geometric Coefficient of Variation 46.7
|
|
Elimination Half-life (t½) of Vevorisertib
Cycle 1 Day 22
|
—
|
10.12 hours
Geometric Coefficient of Variation 87.0
|
—
|
39.33 hours
Geometric Coefficient of Variation 48.6
|
21.25 hours
Geometric Coefficient of Variation 13.8
|
20.03 hours
Geometric Coefficient of Variation 1.6
|
12.94 hours
Geometric Coefficient of Variation 71.8
|
24.59 hours
Geometric Coefficient of Variation 6.9
|
—
|
—
|
—
|
—
|
|
Elimination Half-life (t½) of Vevorisertib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
22.93 hours
Geometric Coefficient of Variation 36.8
|
—
|
20.89 hours
Geometric Coefficient of Variation 70.9
|
—
|
28.78 hours
Geometric Coefficient of Variation 16.3
|
11.46 hours
Geometric Coefficient of Variation NA
Percent Geometric Coefficient of Variation was not calculable when n\<2.
|
SECONDARY outcome
Timeframe: Cycle 1 (Up to approximately 28 days)Population: All participants who received at least 1 dose of study treatment.
DLTs consisted of hematologic or non-hematologic toxicities. Hematologic DLT was any grade (Gr) 4 anemia, Gr 4 neutropenia, Gr 4 thrombocytopenia, Gr 3 lasting \>7 days, Gr 3 thrombocytopenia in the presence of bleeding, or ≥ Gr 3 hyperglycemia. Non-hematologic DLT was any Gr 3, 4 or 5 non-hematologic toxicity with the exception of: (1) Gr 3 nausea, vomiting, diarrhea or responding to optimal medical management within 48 hours; (2) alopecia. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=32 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Dose-Limiting Toxicity (DLT), for the Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 116 weeksPopulation: All participants who received at least 1 dose of study treatment and had ORR data available.
ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=3 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=3 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=2 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=24 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=7 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=2 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=4 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
4.2 Percentage of Participants
Interval 0.11 to 21.12
|
14.3 Percentage of Participants
Interval 0.36 to 57.87
|
50.0 Percentage of Participants
Interval 6.76 to 93.24
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
SECONDARY outcome
Timeframe: Up to approximately 116 weeksPopulation: All participants who received at least 1 dose of study treatment and had BOR data available.
BOR was assessed using RECIST 1.1. Response categories included: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; and Inevaluable: participants who have SD as their best overall response but fail to achieve the protocol-defined duration for SD. Percentage of participants with CR, PR, SD, PD, or inevaluable as a best overall response have been reported.
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=3 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=3 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=2 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=24 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=7 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=2 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=4 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
Complete Response (CR)
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 14.25
|
0 Percentage of Participants
Interval 0.0 to 40.96
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
|
Best Overall Response (BOR)
Partial Response (PR)
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
4.2 Percentage of Participants
Interval 0.11 to 21.12
|
14.3 Percentage of Participants
Interval 0.36 to 57.87
|
50.0 Percentage of Participants
Interval 6.76 to 93.24
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
|
Best Overall Response (BOR)
Stable Disease (SD)
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
66.7 Percentage of Participants
Interval 9.43 to 99.16
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
50.0 Percentage of Participants
Interval 1.26 to 98.74
|
41.7 Percentage of Participants
Interval 22.11 to 63.36
|
42.9 Percentage of Participants
Interval 9.9 to 81.59
|
25.0 Percentage of Participants
Interval 0.63 to 80.59
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
50.0 Percentage of Participants
Interval 6.76 to 93.24
|
|
Best Overall Response (BOR)
Progressive Disease (PD)
|
100.0 Percentage of Participants
Interval 29.24 to 100.0
|
100.0 Percentage of Participants
Interval 29.24 to 100.0
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
66.7 Percentage of Participants
Interval 9.43 to 99.16
|
50.0 Percentage of Participants
Interval 1.26 to 98.74
|
54.2 Percentage of Participants
Interval 32.82 to 74.45
|
28.6 Percentage of Participants
Interval 3.67 to 70.96
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
66.7 Percentage of Participants
Interval 9.43 to 99.16
|
100.0 Percentage of Participants
Interval 15.81 to 100.0
|
50.0 Percentage of Participants
Interval 6.76 to 93.24
|
|
Best Overall Response (BOR)
Inevaluable
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 0.76
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 14.25
|
14.3 Percentage of Participants
Interval 0.36 to 57.87
|
25.0 Percentage of Participants
Interval 0.63 to 80.59
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
SECONDARY outcome
Timeframe: Up to approximately 116 weeksPopulation: All participants who received at least 1 dose of study treatment and had DCR data available.
DCR was defined, per RECIST 1.1, as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\].
Outcome measures
| Measure |
Part 1: Vevorisertib 5 mg QD
n=3 Participants
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=3 Participants
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg
n=1 Participants
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 Participants
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 Participants
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=2 Participants
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=24 Participants
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=7 Participants
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=4 Participants
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=3 Participants
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=2 Participants
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=4 Participants
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
100.0 Percentage of Participants
Interval 29.24 to 100.0
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
50.0 Percentage of Participants
Interval 1.26 to 98.74
|
45.8 Percentage of Participants
Interval 25.55 to 67.18
|
57.1 Percentage of Participants
Interval 18.41 to 90.1
|
75.0 Percentage of Participants
Interval 19.41 to 99.37
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
50.0 Percentage of Participants
Interval 6.76 to 93.24
|
Adverse Events
Part 1: Vevorisertib 5 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Part 1: Vevorisertib 10 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Part 1: Vevorisertib 20 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Vevorisertib 25 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: Vevorisertib 25 mg QOD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Vevorisertib 50 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: Vevorisertib 75 mg QD
Serious events: 12 serious events
Other events: 32 other events
Deaths: 7 deaths
Part 1: Vevorisertib 100 mg QD
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 participants at risk
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 participants at risk
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg QD
n=1 participants at risk
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 participants at risk
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 participants at risk
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 participants at risk
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=32 participants at risk
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 participants at risk
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 participants at risk
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 participants at risk
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 participants at risk
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 participants at risk
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Disease progression
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Part 1: Vevorisertib 5 mg QD
n=4 participants at risk
Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 10 mg QD
n=4 participants at risk
Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 20 mg QD
n=1 participants at risk
Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QD
n=3 participants at risk
Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 25 mg QOD
n=3 participants at risk
Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
|
Part 1: Vevorisertib 50 mg QD
n=3 participants at risk
Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 75 mg QD
n=32 participants at risk
Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
|
Part 1: Vevorisertib 100 mg QD
n=8 participants at risk
Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel
n=5 participants at risk
Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel
n=5 participants at risk
Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
|
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant
n=3 participants at risk
Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant
n=6 participants at risk
Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Ocular hypertension
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Refraction disorder
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 7 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
59.4%
19/32 • Number of events 44 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
75.0%
6/8 • Number of events 12 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
100.0%
3/3 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
2/6 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
100.0%
4/4 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
8/32 • Number of events 13 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
75.0%
3/4 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
28.1%
9/32 • Number of events 12 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
75.0%
3/4 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
8/32 • Number of events 8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 7 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 7 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
31.2%
10/32 • Number of events 11 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
4/32 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Early satiety
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
4/32 • Number of events 7 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
18.8%
6/32 • Number of events 8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 7 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Muscle tone disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Reflexes abnormal
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
4/32 • Number of events 4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
6.2%
2/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
9.4%
3/32 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
15.6%
5/32 • Number of events 6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
8/32 • Number of events 17 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
60.0%
3/5 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
4/32 • Number of events 13 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
3.1%
1/32 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
37.5%
3/8 • Number of events 5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/32 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/8 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/5 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/6 • Up to approximately 120 weeks
The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees not to independently publish the findings except as part of an overall multi-center publication, unless specifically approved in writing by the Sponsor or unless more than 12 months have elapsed since the last participant in the study has completed study treatment.
- Publication restrictions are in place
Restriction type: OTHER