Trial Outcomes & Findings for A Study of PF-06873600 in People With Cancer (NCT NCT03519178)
NCT ID: NCT03519178
Last Updated: 2025-11-14
Results Overview
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to one, the other, or both agents in the combination: Hematologic - grade(G) 4 neutropenia lasting \>7 days; Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 \* 10\^9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour; G≥3 neutropenia with associated infection; G3 thrombocytopenia with clinically significant bleeding as indicated by ≥ G2 bleeding; G4 thrombocytopenia. Nonhematologic: Confirmed case of Drug Induced Liver Injury (DILI) (Hy's Law); G≥3 AEs that were clinically significant.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Cycle 1 (within 28 days after the first dose of study intervention)
Results posted on
2025-11-14
Participant Flow
Participants with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (mBC), with locally recurrent/advanced or metastatic triple negative breast cancer (TNBC) or advanced platinum resistant ovarian/fallopian/peritoneal cancer, were recruited into this study. Two participants assigned to treatment but did not receive any study treatment were not included in any analysis.
Primary outcome measures and secondary outcome measures analysis was final at primary completion date milestone and reported on the same milestone.
Participant milestones
| Measure |
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 Modified Release (MR) 20 mg IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 1 mg Twice a Day (BID)
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-06873600 Treatment
STARTED
|
7
|
5
|
1
|
2
|
2
|
3
|
9
|
7
|
4
|
13
|
10
|
9
|
6
|
45
|
28
|
|
PF-06873600 Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PF-06873600 Treatment
NOT COMPLETED
|
7
|
5
|
1
|
2
|
2
|
3
|
9
|
7
|
4
|
13
|
10
|
9
|
6
|
45
|
28
|
|
Fulvestrant. Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
45
|
28
|
|
Fulvestrant. Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fulvestrant. Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
45
|
28
|
|
Letrozole Treatment
STARTED
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Letrozole Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Letrozole Treatment
NOT COMPLETED
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-Up
STARTED
|
7
|
5
|
1
|
2
|
2
|
3
|
9
|
7
|
4
|
13
|
10
|
9
|
6
|
0
|
0
|
|
Follow-Up
COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
2
|
1
|
6
|
2
|
0
|
0
|
|
Follow-Up
NOT COMPLETED
|
3
|
5
|
1
|
2
|
2
|
3
|
5
|
4
|
3
|
11
|
9
|
3
|
4
|
0
|
0
|
|
Long-term Follow-up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
45
|
28
|
|
Long-term Follow-up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
45
|
28
|
Reasons for withdrawal
| Measure |
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 Modified Release (MR) 20 mg IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 1 mg Twice a Day (BID)
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-06873600 Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
3
|
2
|
|
PF-06873600 Treatment
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
PF-06873600 Treatment
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
4
|
1
|
|
PF-06873600 Treatment
Progressive disease
|
4
|
3
|
1
|
1
|
1
|
1
|
6
|
7
|
3
|
7
|
3
|
5
|
4
|
28
|
8
|
|
PF-06873600 Treatment
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
3
|
2
|
1
|
1
|
2
|
|
PF-06873600 Treatment
Global deterioration of health status
|
2
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
2
|
1
|
1
|
0
|
3
|
0
|
|
PF-06873600 Treatment
Refused further treatment
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
PF-06873600 Treatment
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
3
|
|
PF-06873600 Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
PF-06873600 Treatment
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
9
|
|
Fulvestrant. Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Fulvestrant. Treatment
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Fulvestrant. Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Fulvestrant. Treatment
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
|
Fulvestrant. Treatment
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
30
|
8
|
|
Fulvestrant. Treatment
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
9
|
|
Fulvestrant. Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
|
Fulvestrant. Treatment
Global deterioration of health status
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
|
Fulvestrant. Treatment
Refused further treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Fulvestrant. Treatment
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Letrozole Treatment
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Letrozole Treatment
Progressive disease
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Letrozole Treatment
Global deterioration of health status
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-Up
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
0
|
0
|
|
Follow-Up
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
4
|
1
|
0
|
0
|
0
|
0
|
|
Follow-Up
Withdrawal by Subject
|
3
|
5
|
1
|
2
|
2
|
3
|
5
|
1
|
2
|
6
|
5
|
2
|
2
|
0
|
0
|
|
Follow-Up
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
|
Long-term Follow-up
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Long-term Follow-up
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
32
|
19
|
|
Long-term Follow-up
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
3
|
|
Long-term Follow-up
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Long-term Follow-up
Global deterioration of health status
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of PF-06873600 in People With Cancer
Baseline characteristics by cohort
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 Modified Release (MR) 20 mg IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
7 Participants
n=44 Participants
|
6 Participants
n=45 Participants
|
3 Participants
n=265 Participants
|
11 Participants
n=18 Participants
|
7 Participants
n=15 Participants
|
6 Participants
n=91 Participants
|
6 Participants
n=52 Participants
|
2 Participants
n=53 Participants
|
4 Participants
n=49 Participants
|
34 Participants
n=51 Participants
|
17 Participants
n=52 Participants
|
108 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=91 Participants
|
1 Participants
n=52 Participants
|
3 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
11 Participants
n=51 Participants
|
11 Participants
n=52 Participants
|
43 Participants
n=101 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
9 Participants
n=44 Participants
|
7 Participants
n=45 Participants
|
4 Participants
n=265 Participants
|
13 Participants
n=18 Participants
|
10 Participants
n=15 Participants
|
9 Participants
n=91 Participants
|
7 Participants
n=52 Participants
|
5 Participants
n=53 Participants
|
6 Participants
n=49 Participants
|
45 Participants
n=51 Participants
|
28 Participants
n=52 Participants
|
151 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
1 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
5 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
12 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
8 Participants
n=44 Participants
|
6 Participants
n=45 Participants
|
2 Participants
n=265 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=15 Participants
|
7 Participants
n=91 Participants
|
6 Participants
n=52 Participants
|
4 Participants
n=53 Participants
|
6 Participants
n=49 Participants
|
37 Participants
n=51 Participants
|
27 Participants
n=52 Participants
|
130 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
3 Participants
n=51 Participants
|
1 Participants
n=52 Participants
|
9 Participants
n=101 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
2 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
5 Participants
n=51 Participants
|
8 Participants
n=52 Participants
|
22 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
10 Participants
n=101 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
4 Participants
n=44 Participants
|
6 Participants
n=45 Participants
|
3 Participants
n=265 Participants
|
8 Participants
n=18 Participants
|
8 Participants
n=15 Participants
|
9 Participants
n=91 Participants
|
4 Participants
n=52 Participants
|
5 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
32 Participants
n=51 Participants
|
20 Participants
n=52 Participants
|
108 Participants
n=101 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
1 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
10 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (within 28 days after the first dose of study intervention)Population: Analysis population consisted of all enrolled participants who received at least 1 dose of study intervention and who did not have major treatment deviations during the first cycle (ie, evaluable for the maximum tolerated dose \[MTD\]).
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to one, the other, or both agents in the combination: Hematologic - grade(G) 4 neutropenia lasting \>7 days; Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 \* 10\^9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour; G≥3 neutropenia with associated infection; G3 thrombocytopenia with clinically significant bleeding as indicated by ≥ G2 bleeding; G4 thrombocytopenia. Nonhematologic: Confirmed case of Drug Induced Liver Injury (DILI) (Hy's Law); G≥3 AEs that were clinically significant.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=6 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=8 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=4 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 monthsPopulation: The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment Related AEs were treatment emergent AEs with cause categorized by the investigator as related to study treatment.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2
All-causality AEs
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
45 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2
All-causality SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2
Treatment-related AEs
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
45 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 monthsPopulation: The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. For each laboratory parameter, only participants with evaluable laboratory results were included in the analysis.
Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Activated partial thromboplastin time prolonged · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
33 Participants
|
13 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Activated partial thromboplastin time prolonged · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Anemia · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
19 Participants
|
5 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Anemia · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hemoglobin increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hemoglobin increased · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
International normalized ratio (INR) increased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
29 Participants
|
9 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
International normalized ratio (INR) increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
International normalized ratio (INR) increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
International normalized ratio (INR) increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
International normalized ratio (INR) increased · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Leukocytosis · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
45 Participants
|
26 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Leukocytosis · Grade 1
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Leukocytosis · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Leukocytosis · Grade 2
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Leukocytosis · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count decreased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count decreased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
21 Participants
|
5 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count decreased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count increased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
45 Participants
|
26 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count increased · Grade 1
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Activated partial thromboplastin time prolonged · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Activated partial thromboplastin time prolonged · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Activated partial thromboplastin time prolonged · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Anemia · Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Anemia · Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Anemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hemoglobin increased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
45 Participants
|
26 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hemoglobin increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hemoglobin increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lymphocyte count increased · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Neutrophil count decreased · Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
16 Participants
|
8 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Neutrophil count decreased · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Neutrophil count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Neutrophil count decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Neutrophil count decreased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Platelet count decreased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
28 Participants
|
17 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Platelet count decreased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
8 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Platelet count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Platelet count decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Platelet count decreased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
White blood cell decreased · Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
White blood cell decreased · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
White blood cell decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
16 Participants
|
8 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
White blood cell decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
White blood cell decreased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 monthsPopulation: The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. For each laboratory parameter, only participants with evaluable laboratory results were included in the analysis.
Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alanine aminotransferase increased · Grade 0
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
41 Participants
|
20 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alanine aminotransferase increased · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alanine aminotransferase increased · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alanine aminotransferase increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alanine aminotransferase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alkaline phosphatase increased · Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
31 Participants
|
16 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alkaline phosphatase increased · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alkaline phosphatase increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alkaline phosphatase increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Alkaline phosphatase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Aspartate aminotransferase increased · Grade 0
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
38 Participants
|
16 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Aspartate aminotransferase increased · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Aspartate aminotransferase increased · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Aspartate aminotransferase increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Aspartate aminotransferase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Blood bilirubin increased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
45 Participants
|
19 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Blood bilirubin increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Blood bilirubin increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Blood bilirubin increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Blood bilirubin increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Creatinine increased · Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
21 Participants
|
7 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Creatinine increased · Grade 1
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
22 Participants
|
17 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Creatinine increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Creatinine increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Creatinine increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypercalcemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypercalcemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperglycemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypermagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypermagnesemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoalbuminemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypocalcemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoglycemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypokalemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypomagnesemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyponatremia · Grade 2
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypophosphatemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lipase increased · Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
42 Participants
|
15 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lipase increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lipase increased · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Serum amylase increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypercalcemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
38 Participants
|
22 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoalbuminemia · Grade 4
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypocalcemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
36 Participants
|
13 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypocalcemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypocalcemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypocalcemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoglycemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
13 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
44 Participants
|
23 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoglycemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoglycemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoglycemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypokalemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
33 Participants
|
19 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypokalemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypokalemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypokalemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypomagnesemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
24 Participants
|
14 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypomagnesemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypomagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypomagnesemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyponatremia · Grade 0
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
40 Participants
|
20 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyponatremia · Grade 1
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypercalcemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypercalcemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyponatremia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyponatremia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypophosphatemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
39 Participants
|
22 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperglycemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
23 Participants
|
12 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypophosphatemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypophosphatemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperglycemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypophosphatemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperglycemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperglycemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperkalemia · Grade 0
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
42 Participants
|
23 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperkalemia · Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperkalemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperkalemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hyperkalemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypermagnesemia · Grade 0
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
12 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
42 Participants
|
15 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypermagnesemia · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypermagnesemia · Grade 2
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
NA Participants
Not defined in CTCAE v4.03.
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypernatremia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
44 Participants
|
24 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypernatremia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypernatremia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypernatremia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypernatremia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoalbuminemia · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
35 Participants
|
18 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoalbuminemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Hypoalbuminemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lipase increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Lipase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Serum amylase increased · Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
12 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
41 Participants
|
20 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Serum amylase increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Serum amylase increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2
Serum amylase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 monthsPopulation: The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. For each vital sign measurement, only participants with evaluable vital sign results were included in the analysis.
Pre-defined criteria included: 1) systolic blood pressure (SBP) (mm Hg) minimum (min) value \<90; 2) SBP change from baseline (CFB) (mm Hg) maximum (max) decrease \>=30 or max increase \>=30; 3) diastolic blood pressure (DBP) (mm Hg) min \<50; 4) DBP CFB (mm Hg) max decrease \>=20 or max increase \>=20; 5) supine heart rate (HR) beats per minute (bpm) min \<40 or max \>120.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
SBP CFB (mm Hg) >= 30 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
SBP CFB (mm Hg) >= 30 decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
2 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
Heart rate (bpm) <40
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
Heart rate (bpm) >120
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
DBP (mm Hg) <50
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
DBP CFB (mm Hg) >=20 increase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
DBP CFB (mm Hg) >=20 decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2
SBP (mm Hg) <90
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 monthsPopulation: The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Only participants with evaluable ECG results were included in the analysis.
ECG pre-defined categories for QTc interval adjusted according to Fridericia formula (QTcF) (msec) included: 450 \<= max. \<=480, 481 \<= max. \<=500, max \>=501; QTcF CFB: 30 \< max \<=60, max \>60; for PR and QRS: PR (msec): max \>=300; PR increase from baseline: Baseline \>200 and max. \>=25% increase, Baseline \<=200 and max. \>=50% increase; QRS (msec): max \>=200; QRS (msec) increase from baseline: Baseline \>100 and max. \>=25% increase, Baseline \<=100 and max. \>=50% increase. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
PR interval not otherwise specified (NOS) (msec) baseline >200 and percent change >=25%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
PR interval NOS (msec) baseline <=200 and percent change >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QRS interval not otherwise specified (NOS) (msec): baseline >100 and change from baseline >=25%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QRS interval not otherwise specified (NOS) (msec): baseline <=100 and change from baseline >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QTcF NOS (msec): 450 <= value <=480
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
14 Participants
|
5 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QTcF NOS (msec): 481 <= value <=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QTcF NOS (msec): value >=501
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QTcF NOS (msec): 30 <= change from baseline <=60
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2
QTcF NOS (msec): change from baseline >60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)Population: For Part 2: the response evaluable population included all participants who received at least 1 dose of study treatment and had baseline disease and at least 1 post baseline disease assessment.
ORR: percentage of participants with confirmed complete response (CR) or partial response (PR). Response evaluation criteria in solid tumors (RECIST) v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions that had a reduction in short axis to less than (\<) 10 millimeter (mm). Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Any radiological assessments taken more than 30 days after the last dose of study therapy or after antineoplastic agents other than study treatments taken by the participants was excluded from the best overall response derivation. Confirmation of CR or PR was to be at least 4 weeks apart from the previous radiological assessment.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=45 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=22 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR): Part 2
|
6.7 Percentage of participants
Interval 1.4 to 18.3
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on Cycle 1 Day 1 (C1D1); Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric coefficient of variation \[CV\]).
The maximum observed concentration of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. The Cmax value was observed directly from data.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=43 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=24 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2
|
5.39 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
22.1 Nanogram per milliliter
Geometric Coefficient of Variation 31.9
|
29.1 Nanogram per milliliter
Geometric Coefficient of Variation 90.8
|
164.1 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
243.5 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
202.6 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
388.1 Nanogram per milliliter
Geometric Coefficient of Variation 9
|
276.4 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
393.8 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
225.4 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
228.5 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
121.8 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
43.51 Nanogram per milliliter
Geometric Coefficient of Variation 121
|
224.9 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
181.4 Nanogram per milliliter
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=43 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=24 Participants
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax at Steady State (Tmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2
|
2.17 Hour
Interval 2.17 to 2.17
|
1.25 Hour
Interval 0.5 to 2.0
|
2.02 Hour
Interval 2.0 to 2.03
|
0.983 Hour
Interval 0.5 to 1.9
|
2.17 Hour
Interval 1.1 to 5.47
|
1.90 Hour
Interval 0.517 to 3.0
|
3.64 Hour
Interval 2.0 to 5.92
|
2.02 Hour
Interval 0.517 to 6.0
|
3.49 Hour
Interval 0.55 to 6.03
|
1.97 Hour
Interval 0.533 to 5.95
|
2.52 Hour
Interval 0.5 to 3.0
|
2.00 Hour
Interval 0.517 to 10.3
|
10.0 Hour
Interval 5.35 to 10.2
|
1.98 Hour
Interval 1.0 to 4.17
|
1.94 Hour
Interval 0.967 to 5.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
AUClast of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=9 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1
|
18.3 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
39.2 Hour*nanogram per milliliter
Geometric Coefficient of Variation 58.3
|
96.6 Hour*nanogram per milliliter
Geometric Coefficient of Variation 442
|
599.4 Hour*nanogram per milliliter
Geometric Coefficient of Variation 53
|
1295 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25
|
787.9 Hour*nanogram per milliliter
Geometric Coefficient of Variation 59
|
2510 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25
|
1395 Hour*nanogram per milliliter
Geometric Coefficient of Variation 38
|
1976 Hour*nanogram per milliliter
Geometric Coefficient of Variation 49
|
1034 Hour*nanogram per milliliter
Geometric Coefficient of Variation 43
|
1040 Hour*nanogram per milliliter
Geometric Coefficient of Variation 46
|
596.8 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33
|
192.0 Hour*nanogram per milliliter
Geometric Coefficient of Variation 201
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
AUCinf of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=5 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=5 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1
|
21.0 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
45.2 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
101 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
648.4 Hour*nanogram per milliliter
Geometric Coefficient of Variation 60
|
1492 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20
|
892.6 Hour*nanogram per milliliter
Geometric Coefficient of Variation 73
|
2010 Hour*nanogram per milliliter
Geometric Coefficient of Variation 3400
|
1614 Hour*nanogram per milliliter
Geometric Coefficient of Variation 48
|
1875 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41
|
884.3 Hour*nanogram per milliliter
Geometric Coefficient of Variation 34
|
1142 Hour*nanogram per milliliter
Geometric Coefficient of Variation 50
|
593.3 Hour*nanogram per milliliter
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
CL/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=5 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=3 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1
|
47.6 Liter per hour
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
44.2 Liter per hour
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
49.7 Liter per hour
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
15.43 Liter per hour
Geometric Coefficient of Variation 60
|
16.78 Liter per hour
Geometric Coefficient of Variation 20
|
28.04 Liter per hour
Geometric Coefficient of Variation 73
|
10.3 Liter per hour
Geometric Coefficient of Variation 17.4
|
21.70 Liter per hour
Geometric Coefficient of Variation 48
|
26.63 Liter per hour
Geometric Coefficient of Variation 41
|
28.26 Liter per hour
Geometric Coefficient of Variation 34
|
21.87 Liter per hour
Geometric Coefficient of Variation 50
|
42.14 Liter per hour
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
Vz/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=5 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=3 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1
|
111 Liter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
116 Liter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
141 Liter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
55.32 Liter
Geometric Coefficient of Variation 28
|
61.33 Liter
Geometric Coefficient of Variation 20
|
97.32 Liter
Geometric Coefficient of Variation 56
|
55.5 Liter
Geometric Coefficient of Variation 60.0
|
86.06 Liter
Geometric Coefficient of Variation 37
|
79.74 Liter
Geometric Coefficient of Variation 15
|
83.54 Liter
Geometric Coefficient of Variation 17
|
72.18 Liter
Geometric Coefficient of Variation 37
|
132.2 Liter
Geometric Coefficient of Variation 52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Standard deviation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the mean (standard deviation).
t1/2 of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=5 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=3 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1
|
1.61 Hour
Standard Deviation NA
Only 1 participant evaluable.
|
1.82 Hour
Standard Deviation NA
Only 1 participant evaluable.
|
1.96 Hour
Standard Deviation NA
Only 1 participant evaluable.
|
2.567 Hour
Standard Deviation 0.82033
|
2.540 Hour
Standard Deviation 0.14394
|
2.446 Hour
Standard Deviation 0.54574
|
2.39 Hour
Standard Deviation 3.74
|
2.809 Hour
Standard Deviation 0.59669
|
2.163 Hour
Standard Deviation 0.74732
|
2.128 Hour
Standard Deviation 0.73966
|
2.428 Hour
Standard Deviation 0.87316
|
2.250 Hour
Standard Deviation 0.77350
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
Css,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=8 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=6 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=39 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=21 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Maximum Concentration (Css,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2
|
10.9 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
18.2 Nanogram per milliliter
Geometric Coefficient of Variation 45.4
|
46.3 Nanogram per milliliter
Geometric Coefficient of Variation 126
|
124.3 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
382.4 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
246.4 Nanogram per milliliter
Geometric Coefficient of Variation 40
|
362 Nanogram per milliliter
Geometric Coefficient of Variation 399
|
290.2 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
335.2 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
305.0 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
276.5 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
82.11 Nanogram per milliliter
Geometric Coefficient of Variation 72
|
273.5 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
250.5 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
—
|
SECONDARY outcome
Timeframe: Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tss,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=8 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=6 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=39 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=21 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration at Steady State (Tss,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2
|
1.00 Hour
Interval 1.0 to 1.0
|
1.25 Hour
Interval 0.5 to 2.0
|
1.20 Hour
Interval 0.5 to 1.9
|
2.00 Hour
Interval 0.25 to 2.13
|
1.95 Hour
Interval 0.9 to 5.7
|
1.92 Hour
Interval 1.0 to 2.92
|
2.01 Hour
Interval 2.0 to 2.02
|
2.23 Hour
Interval 0.0 to 4.05
|
1.98 Hour
Interval 1.1 to 4.25
|
1.88 Hour
Interval 0.517 to 2.12
|
2.08 Hour
Interval 1.82 to 3.93
|
2.99 Hour
Interval 0.0 to 4.0
|
1.95 Hour
Interval 0.917 to 4.02
|
1.97 Hour
Interval 0.933 to 5.88
|
—
|
SECONDARY outcome
Timeframe: Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
Css,min of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=9 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=8 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=6 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=38 Participants
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=21 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Minimum Plasma Concentration (Css,Min) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2
|
0.0000 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
0.000 Nanogram per milliliter
Geometric Coefficient of Variation 0.000
|
1.19 Nanogram per milliliter
Geometric Coefficient of Variation 23.6
|
5.499 Nanogram per milliliter
Geometric Coefficient of Variation 5
|
37.63 Nanogram per milliliter
Geometric Coefficient of Variation 112
|
21.28 Nanogram per milliliter
Geometric Coefficient of Variation 130
|
52.1 Nanogram per milliliter
Geometric Coefficient of Variation 80.4
|
25.56 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
25.63 Nanogram per milliliter
Geometric Coefficient of Variation 101
|
21.25 Nanogram per milliliter
Geometric Coefficient of Variation 106
|
13.33 Nanogram per milliliter
Geometric Coefficient of Variation 204
|
45.78 Nanogram per milliliter
Geometric Coefficient of Variation 49
|
23.67 Nanogram per milliliter
Geometric Coefficient of Variation 156
|
19.16 Nanogram per milliliter
Geometric Coefficient of Variation 131
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
AUCss,tau of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=7 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=8 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=6 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady-State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,Tau) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1
|
25.3 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
51.4 Hour*nanogram per milliliter
Geometric Coefficient of Variation 86.9
|
150 Hour*nanogram per milliliter
Geometric Coefficient of Variation 483
|
448.8 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25
|
1695 Hour*nanogram per milliliter
Geometric Coefficient of Variation 34
|
1010 Hour*nanogram per milliliter
Geometric Coefficient of Variation 40
|
2060 Hour*nanogram per milliliter
Geometric Coefficient of Variation 2360
|
1372 Hour*nanogram per milliliter
Geometric Coefficient of Variation 39
|
1607 Hour*nanogram per milliliter
Geometric Coefficient of Variation 34
|
1229 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41
|
1273 Hour*nanogram per milliliter
Geometric Coefficient of Variation 50
|
636.8 Hour*nanogram per milliliter
Geometric Coefficient of Variation 59
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
CLss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=7 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
n=6 Participants
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady-State Apparent Oral Plasma Clearance (CLss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1
|
39.5 Liter per hour
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
23.0 Liter per hour
Geometric Coefficient of Variation 38.9
|
10.4 Liter per hour
Geometric Coefficient of Variation 33.2
|
22.28 Liter per hour
Geometric Coefficient of Variation 24
|
14.78 Liter per hour
Geometric Coefficient of Variation 34
|
24.76 Liter per hour
Geometric Coefficient of Variation 40
|
14.8 Liter per hour
Geometric Coefficient of Variation 17.0
|
25.54 Liter per hour
Geometric Coefficient of Variation 39
|
21.99 Liter per hour
Geometric Coefficient of Variation 44
|
20.35 Liter per hour
Geometric Coefficient of Variation 41
|
19.63 Liter per hour
Geometric Coefficient of Variation 49
|
47.08 Liter per hour
Geometric Coefficient of Variation 59
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric CV).
Vss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=6 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=6 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=5 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1
|
—
|
53.3 Liter
Geometric Coefficient of Variation 98.4
|
124 Liter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
72.17 Liter
Geometric Coefficient of Variation 19
|
57.62 Liter
Geometric Coefficient of Variation 29
|
99.62 Liter
Geometric Coefficient of Variation 35
|
70.8 Liter
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
99.03 Liter
Geometric Coefficient of Variation 48
|
75.41 Liter
Geometric Coefficient of Variation 17
|
75.71 Liter
Geometric Coefficient of Variation 32
|
80.33 Liter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data \<3 at that time point.
Rac of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=1 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 Participants
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=6 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=5 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=5 Participants
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=4 Participants
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
n=5 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=6 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on AUC (Rac) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1
|
1.210 Ratio
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
1.160 Ratio
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
1.53 Ratio
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
0.7263 Ratio
Geometric Coefficient of Variation 28
|
1.045 Ratio
Geometric Coefficient of Variation 17
|
1.254 Ratio
Geometric Coefficient of Variation 49
|
0.822 Ratio
Geometric Coefficient of Variation NA
Only 1 participant evaluable.
|
0.8893 Ratio
Geometric Coefficient of Variation 32
|
1.260 Ratio
Geometric Coefficient of Variation 25
|
1.191 Ratio
Geometric Coefficient of Variation 29
|
1.268 Ratio
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6 hours post-dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac,cmax of PF-06873600 after multiple doses of study intervention when given as in combination with fulvestrant (Part 2) was reported.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
n=36 Participants
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=19 Participants
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on Cmax (Observed) (Rac,Cmax) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 2
|
1.161 Ratio
Geometric Coefficient of Variation 78
|
1.381 Ratio
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening and Cycle 2 Day 1Population: The biomarker analysis population was all enrolled participants with PD biomarkers evaluated at pre-and/post dose.
Level of the PD marker, pRb, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percentage changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=1 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=7 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Biomarker Phospho-retinoblastoma Protein (pRb) in Tumor Tissue in Participants - Part 1 + Part 2
|
—
|
—
|
—
|
—
|
-84.44 Percentage of change
Only 1 participant evaluable.
|
-11.11 Percentage of change
Interval -172.414 to 326.323
|
—
|
—
|
—
|
—
|
-77.50 Percentage of change
Only 1 participant evaluable.
|
—
|
—
|
-30.43 Percentage of change
Interval -103.371 to 184.82
|
—
|
SECONDARY outcome
Timeframe: Screening and Cycle 2 Day 1Population: The biomarker analysis population was all enrolled participants with PD biomarkers evaluated at pre-and/post dose.
Level of the PD marker, Ki67, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percent changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.
Outcome measures
| Measure |
Part 1A PF-06873600 1 mg Twice a Day (BID)
Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=1 Participants
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 Participants
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=1 Participants
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 IR 25 mg BID
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle
|
Part 1C PF-06873600 MR 30 mg BID Long Release
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=7 Participants
Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD Biomarker Ki67 in Tumor Tissue in Participants - Part 1 + Part 2
|
—
|
—
|
—
|
—
|
-63.64 Percentage of change
Only 1 participant evaluable.
|
-6.67 Percentage of change
Interval -99.91 to 138.742
|
—
|
—
|
—
|
—
|
-90.00 Percentage of change
Only 1 participant evaluable.
|
—
|
—
|
-33.33 Percentage of change
Interval -60.398 to 8.593
|
—
|
Adverse Events
Part 1A PF-06873600 1 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1A PF-06873600 2 mg BID
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1A PF-06873600 5 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1A PF-06873600 10 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1A PF-06873600 25 mg BID
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Part 1A PF-06873600 25 mg BID Biomarker
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1A PF-06873600 35 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Part 1A PF-06873600 50 mg BID
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
Part 1B PF-06873600 25 mg BID IR/Fulvestrant Combination
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1C PF-06873600 MR 20 mg IR 25 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1C PF-06873600 MR 30 mg BID Long Release
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
Serious events: 9 serious events
Other events: 45 other events
Deaths: 6 deaths
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
Serious events: 5 serious events
Other events: 25 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part 1A PF-06873600 1 mg BID
n=1 participants at risk
Participants in Part 1A received PF-06873600 1 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 participants at risk
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 participants at risk
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 participants at risk
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 participants at risk
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 participants at risk
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 participants at risk
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 participants at risk
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 participants at risk
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID IR/Fulvestrant Combination
n=9 participants at risk
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 participants at risk
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 mg IR 25 mg BID
n=5 participants at risk
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 participants at risk
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 participants at risk
Participants in Part 2A had received CDK4/6i treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 participants at risk
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Disease progression
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Part 1A PF-06873600 1 mg BID
n=1 participants at risk
Participants in Part 1A received PF-06873600 1 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 2 mg BID
n=2 participants at risk
Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 5 mg BID
n=2 participants at risk
Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 10 mg BID
n=3 participants at risk
Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID
n=9 participants at risk
Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 25 mg BID Biomarker
n=7 participants at risk
Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg BID
n=4 participants at risk
Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off
n=13 participants at risk
Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1A PF-06873600 50 mg BID
n=10 participants at risk
Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1B PF-06873600 25 mg BID IR/Fulvestrant Combination
n=9 participants at risk
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
|
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination
n=7 participants at risk
Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 20 mg IR 25 mg BID
n=5 participants at risk
Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 1C PF-06873600 MR 30 mg BID Long Release
n=6 participants at risk
Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination
n=45 participants at risk
Participants in Part 2A had received CDK4/6i treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination
n=28 participants at risk
Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
55.6%
5/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
100.0%
4/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
60.0%
6/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
55.6%
5/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
71.4%
5/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
60.0%
3/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
3/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
46.7%
21/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
39.3%
11/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
17.9%
5/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Asthenopia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
2/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
13.3%
6/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
100.0%
2/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
10/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
17.9%
5/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
4/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
44.4%
4/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
2/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
4/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.9%
13/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
4/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.9%
13/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
21.4%
6/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
100.0%
2/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
6/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
71.4%
5/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
69.2%
9/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
60.0%
6/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
6/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
71.4%
5/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
2/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
4/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
30/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
71.4%
20/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
44.4%
4/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
38.5%
5/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
60.0%
6/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
37.8%
17/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
46.4%
13/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Chills
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Death
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Facial pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
61.5%
8/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
62.2%
28/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
21.4%
6/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Localised oedema
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Malaise
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
General disorders
Thirst
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
100.0%
4/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
71.4%
5/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
60.0%
3/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
66.7%
4/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
18/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
100.0%
4/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
44.4%
4/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
2/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
13.3%
6/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
57.1%
4/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
3/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
9/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
17.8%
8/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
42.9%
3/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
100.0%
1/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
17.8%
8/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
17.9%
5/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
13.3%
6/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
13.3%
6/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
75.0%
3/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
2/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
26.7%
12/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
6.7%
3/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
2/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
18/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
35.7%
10/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Product Issues
Device breakage
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
5/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
4/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
44.4%
4/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
75.0%
3/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
4/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
40.0%
2/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
37.8%
17/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
28.6%
8/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Chronic cutaneous lupus erythematosus
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
50.0%
1/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
30.0%
3/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
33.3%
2/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
5/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
4.4%
2/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
14.3%
4/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
2.2%
1/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/2 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
10.0%
1/10 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
8.9%
4/45 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Day 1 up to 28 days after the last dose of study intervention, up to approximately 36.6 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER