Trial Outcomes & Findings for A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma (NCT NCT03312530)
NCT ID: NCT03312530
Last Updated: 2023-02-28
Results Overview
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. New or pre-existing conditions which worsened during the study were also considered AEs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Randomization up to end of study (up to approximately 3 years, 7 months)
Results posted on
2023-02-28
Participant Flow
The study was conducted at 16 centers in 8 countries.
A total of 62 participants were screened, of which a total of 49 participants were enrolled.
Participant milestones
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
16
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
16
|
15
|
Reasons for withdrawal
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
5
|
4
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant in another sponsor study.
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
1
|
0
|
2
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant summarized as 'ongoing' due to missing data entry for Long-term Follow Up period on eCRF
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
66.5 Years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
68.0 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
64.1 Years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
61.5 Years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
64.3 Years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Randomization up to end of study (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. New or pre-existing conditions which worsened during the study were also considered AEs.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From randomization to the first occurrence of a response as defined above (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
ORR was defined as a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and was analyzed in the safety evaluable population and in the biomarker-selected sub-populations of t(11;14) and RAS mutations.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
Safety Population
|
16.7 Percentage of Participants
Interval 0.0 to 54.82
|
33.3 Percentage of Participants
Interval 0.0 to 79.39
|
0 Percentage of Participants
Interval 0.0 to 8.33
|
31.3 Percentage of Participants
Interval 5.41 to 57.09
|
26.7 Percentage of Participants
Interval 0.95 to 52.38
|
|
Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
t(11;14) Population
|
—
|
100 Percentage of Participants
Interval 50.0 to 100.0
|
0 Percentage of Participants
Interval 0.0 to 50.0
|
100 Percentage of Participants
Interval 75.0 to 100.0
|
80.0 Percentage of Participants
Interval 34.94 to 100.0
|
|
Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
RAS Mutation Population
|
0 Percentage of Participants
Interval 0.0 to 25.0
|
100 Percentage of Participants
Interval 50.0 to 100.0
|
0 Percentage of Participants
Interval 0.0 to 25.0
|
14.3 Percentage of Participants
Interval 0.0 to 47.35
|
37.5 Percentage of Participants
Interval 0.0 to 77.3
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
Clinical benefit rate (CBR) was defined as a minimal response (MR) or better (PR,VGPR, CR, sCR).
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Benefit as Determined by the Investigator Using IMWG Response Criteria
|
33.3 Percentage of Participants
Interval 0.0 to 79.39
|
33.3 Percentage of Participants
Interval 0.0 to 79.39
|
0 Percentage of Participants
Interval 0.0 to 8.33
|
43.8 Percentage of Participants
Interval 16.32 to 71.18
|
33.3 Percentage of Participants
Interval 6.14 to 60.52
|
SECONDARY outcome
Timeframe: From enrollment or first treatment date to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
PFS was defined as the time from randomization (for randomized participants) or first treatment date (for non-ranomized participants) to the first occurrence of disease progression or relapse as determined by the investigator using the IMWG criteria or death from any cause during the study, whichever occurred first.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) as Determined by the Investigator Using IMWG Response Criteria
|
1.7 Months
Interval 0.9 to 3.7
|
3.4 Months
Interval 2.1 to 4.6
|
2.8 Months
Interval 1.9 to 4.7
|
4.9 Months
Interval 1.9 to 10.3
|
3.8 Months
Interval 1.4 to 4.7
|
SECONDARY outcome
Timeframe: Time from the first observation of partial response (PR) or better to the time of disease progression (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
DOR was applicable to participants who achieved at least a PR, and was measured from the first observation of PR or better to the time of disease progression.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=1 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=2 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=5 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR) as Determined by the Investigator Using IMWG Response Criteria
|
11.5 Months
NA = not estimable, could not be calculated due to too few events.
|
4.9 Months
Interval 2.3 to
NA = not estimable, could not be calculated due to too few events.
|
15.2 Months
Interval 1.9 to
NA = not estimable, could not be calculated due to too few events.
|
NA Months
Interval 1.9 to
NA = not estimable, could not be calculated due to too few events.
|
—
|
SECONDARY outcome
Timeframe: From randomization until death from any cause (up to approximately 3 years, 7 months)Population: The safety evaluable population included all participants who received any amount of study drug.
OS was defined as the time from randomization until death from any cause.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
11.4 Months
Interval 6.3 to 13.9
|
14.3 Months
Interval 14.1 to
NA = not estimable, could not be calculated due to too few events.
|
12.9 Months
Interval 3.2 to
NA = not estimable, could not be calculated due to too few events.
|
13.5 Months
Interval 8.0 to 26.9
|
22.0 Months
Interval 15.5 to
NA = not estimable, could not be calculated due to too few events.
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms A, B, and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
AUC0-24hr area under the plasma concentration-time curve from time 0 to 24 hrs
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=11 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=9 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of Cobimetinib
|
2390 hr*ng/mL
Geometric Coefficient of Variation 53.4
|
3190 hr*ng/mL
Geometric Coefficient of Variation 55.3
|
—
|
2540 hr*ng/mL
Geometric Coefficient of Variation 78.1
|
2900 hr*ng/mL
Geometric Coefficient of Variation 54.6
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms A, B, and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
Cmax is the maximum observed plasma concentration at steady state.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=5 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=13 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=12 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Cobimetinib
|
157 ng/mL
Geometric Coefficient of Variation 63.5
|
192 ng/mL
Geometric Coefficient of Variation 61.7
|
—
|
148 ng/mL
Geometric Coefficient of Variation 72.6
|
166 ng/mL
Geometric Coefficient of Variation 61.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms A, B, and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
Tmax is the time to reach Cmax.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=5 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=13 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=12 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Cobimetinib
|
4.00 hr
Interval 2.1 to 4.02
|
4.00 hr
Interval 2.05 to 5.73
|
—
|
4.00 hr
Interval 2.0 to 6.08
|
4.00 hr
Interval 2.23 to 6.37
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms B and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
AUClast=area under the plasma concentration-time curve (samples collected to 8hr postdose on C1D15)
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=5 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=13 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=11 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
AUClast of Venetoclax
|
4.96 hr*ug/mL
Geometric Coefficient of Variation 67.2
|
5.13 hr*ug/mL
Geometric Coefficient of Variation 57.0
|
6.52 hr*ug/mL
Geometric Coefficient of Variation 63.7
|
6.52 hr*ug/mL
Geometric Coefficient of Variation 51.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms B and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
Cmax is the maximum observed plasma concentration at steady state.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=5 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=13 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=11 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Cmax of Venetoclax
|
1.25 ug/mL
Geometric Coefficient of Variation 81.0
|
1.16 ug/mL
Geometric Coefficient of Variation 48.7
|
1.32 ug/mL
Geometric Coefficient of Variation 55.3
|
1.35 ug/mL
Geometric Coefficient of Variation 18.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)Population: The PK population included participants from Arms B and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
Tmax is the time to reach Cmax.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=4 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=5 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=13 Participants
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=11 Participants
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Tmax of Venetoclax
|
5.73 hr
Interval 3.92 to 5.77
|
5.65 hr
Interval 3.75 to 5.78
|
6.00 hr
Interval 3.95 to 8.5
|
5.92 hr
Interval 0.0 to 8.17
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3 (cycle length: 28 days); at treatment discontinuation visit (up to approximately 3 years, 7 months)Population: The immunogenicity analysis population for atezolizumab consisted of all participants from Arm C with any ADA assessment.
Outcome measures
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=14 Participants
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
Adverse Events
Safety Run-In: Cobimetinib + Venetoclax
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
A: Cobimetinib
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
B: Cobimetinib + Venetoclax
Serious events: 12 serious events
Other events: 15 other events
Deaths: 11 deaths
C: Cobimetinib + Venetoclax + Atezolizumab
Serious events: 11 serious events
Other events: 15 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 participants at risk
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 participants at risk
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 participants at risk
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 participants at risk
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 participants at risk
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
INTESTINAL ULCER
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
HAEMOPHILUS SEPSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
INFECTION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
LISTERIA SEPSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PNEUMOCOCCAL BACTERAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
25.0%
4/16 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PROSTATE INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
RESPIROVIRUS TEST POSITIVE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
Other adverse events
| Measure |
Safety Run-In: Cobimetinib + Venetoclax
n=6 participants at risk
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
|
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
n=6 participants at risk
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
|
A: Cobimetinib
n=6 participants at risk
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
B: Cobimetinib + Venetoclax
n=16 participants at risk
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
C: Cobimetinib + Venetoclax + Atezolizumab
n=15 participants at risk
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
STOMATITIS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
37.5%
6/16 • Number of events 10 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 8 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
56.2%
9/16 • Number of events 11 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
60.0%
9/15 • Number of events 14 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DIATHESIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
33.3%
2/6 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 9 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
26.7%
4/15 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
50.0%
3/6 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
66.7%
4/6 • Number of events 10 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
46.7%
7/15 • Number of events 17 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
18.8%
3/16 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
5/15 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
BLEPHARITIS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
BLEPHAROCHALASIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
CHALAZION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
DETACHMENT OF RETINAL PIGMENT EPITHELIUM
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
EYE HAEMORRHAGE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
OPTIC NERVE CUPPING
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
SUBRETINAL FLUID
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
SWELLING OF EYELID
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ANORECTAL DISCOMFORT
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
83.3%
5/6 • Number of events 10 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
100.0%
6/6 • Number of events 9 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
81.2%
13/16 • Number of events 17 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
86.7%
13/15 • Number of events 21 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
DRY MOUTH
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
6/6 • Number of events 7 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
66.7%
4/6 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
31.2%
5/16 • Number of events 7 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
66.7%
10/15 • Number of events 11 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Gastrointestinal disorders
PROCTITIS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
ASTHENIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
CHEST PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
FATIGUE
|
66.7%
4/6 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
18.8%
3/16 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
FEELING COLD
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
OEDEMA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
PAIN
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
18.8%
3/16 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
BRONCHIOLITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
CANDIDA INFECTION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
IMPETIGO
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
ORAL HERPES
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
RASH PUSTULAR
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Injury, poisoning and procedural complications
EYE CONTUSION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Injury, poisoning and procedural complications
FALL
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
AMYLASE INCREASED
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD CALCIUM INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
50.0%
3/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
50.0%
3/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
25.0%
4/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
INFLUENZA A VIRUS TEST POSITIVE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
LIPASE INCREASED
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 7 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
18.8%
3/16 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
TROPONIN T INCREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
VITAMIN B12 DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
FOLATE DEFICIENCY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
20.0%
3/15 • Number of events 6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
12.5%
2/16 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
18.8%
3/16 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
AUTONOMIC NEUROPATHY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
DYSAESTHESIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
HEADACHE
|
33.3%
2/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
HYPERAESTHESIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
HYPOAESTHESIA
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
PARAESTHESIA
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
RENAL FAILURE
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Reproductive system and breast disorders
BALANOPOSTHITIS
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
13.3%
2/15 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
5/15 • Number of events 5 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
33.3%
2/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 3 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
2/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
50.0%
3/6 • Number of events 4 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
33.3%
5/15 • Number of events 6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 2 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Vascular disorders
ESSENTIAL HYPERTENSION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/16 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
16.7%
1/6 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.7%
1/15 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
|
Vascular disorders
PERIPHERAL VENOUS DISEASE
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/6 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
6.2%
1/16 • Number of events 1 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
0.00%
0/15 • Randomization up to end of study (up to approximately 3 years, 7 months)
AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER