Trial Outcomes & Findings for Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors (NCT NCT01286987)
NCT ID: NCT01286987
Last Updated: 2019-01-10
Results Overview
Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \[mm\] on the case report form \[CRF\]) and the reduction of the shortest diameter of all nodal lesions to less than \[\<\] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
113 participants
Primary outcome timeframe
From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Results posted on
2019-01-10
Participant Flow
Study was conducted in two parts: Part 1 was dose escalation phase (to determine the maximum tolerated dose \[MTD\]) and Part 2 was the dose expansion phase conducted at MTD determined in Part 1. Participants were different in both of the Parts.
Participant milestones
| Measure |
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
STARTED
|
3
|
3
|
3
|
3
|
3
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Colorectal Cancer
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Prostate Cancer
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Ewing Cancer
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Pancreatic Cancer
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Ovarian/ Peritoneal Cancer
|
1
|
1
|
2
|
3
|
3
|
4
|
4
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Breast Cancer
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
NOT COMPLETED
|
3
|
3
|
3
|
3
|
3
|
6
|
5
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
11
|
12
|
24
|
3
|
|
Part 2: Dose Expansion
Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
11
|
10
|
12
|
23
|
3
|
|
Part 2: Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
1
|
|
Part 2: Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
10
|
10
|
12
|
24
|
2
|
Reasons for withdrawal
| Measure |
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
Clinical Progression
|
1
|
1
|
0
|
1
|
1
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Progressive Disease
|
2
|
2
|
3
|
2
|
1
|
5
|
5
|
3
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Physician Decision
|
0
|
0
|
0
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0
|
1
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Part 2: Dose Expansion
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Part 2: Dose Expansion
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2: Dose Expansion
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
6
|
7
|
11
|
19
|
2
|
|
Part 2: Dose Expansion
Clinical Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
2
|
0
|
|
Part 2: Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1: Talazoparib 25 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 50 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 900 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
n=12 Participants
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=11 Participants
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
n=10 Participants
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
n=12 Participants
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
n=23 Participants
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Prostate Cancer)
n=3 Participants
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
77.7 years
STANDARD_DEVIATION 3.51 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 9.07 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 11.50 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 5.77 • n=21 Participants
|
61.3 years
STANDARD_DEVIATION 19.00 • n=8 Participants
|
48.2 years
STANDARD_DEVIATION 8.66 • n=8 Participants
|
45.0 years
STANDARD_DEVIATION 18.25 • n=24 Participants
|
38.8 years
STANDARD_DEVIATION 13.73 • n=42 Participants
|
46.5 years
STANDARD_DEVIATION 11.47 • n=42 Participants
|
54.2 years
STANDARD_DEVIATION 10.93 • n=42 Participants
|
65.2 years
STANDARD_DEVIATION 7.71 • n=42 Participants
|
28.7 years
STANDARD_DEVIATION 15.18 • n=36 Participants
|
64.0 years
STANDARD_DEVIATION 10.45 • n=36 Participants
|
57.3 years
STANDARD_DEVIATION 8.14 • n=24 Participants
|
53.7 years
STANDARD_DEVIATION 16.80 • n=135 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
76 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
34 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
3 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
3 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
4 participants
n=42 Participants
|
9 participants
n=42 Participants
|
11 participants
n=42 Participants
|
10 participants
n=42 Participants
|
10 participants
n=36 Participants
|
23 participants
n=36 Participants
|
3 participants
n=24 Participants
|
101 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
3 participants
n=135 Participants
|
PRIMARY outcome
Timeframe: From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)Population: Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type.
Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \[mm\] on the case report form \[CRF\]) and the reduction of the shortest diameter of all nodal lesions to less than \[\<\] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=13 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=14 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=23 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=1 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=20 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=31 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=2 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
8 participants
|
12 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)Population: Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease \[SD\] and progressive disease \[PD\]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to \< 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference to baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=13 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=14 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=23 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=1 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=20 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=31 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response
Partial Response (PR)
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
7 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Stable Disease (SD)
|
2 participants
|
4 participants
|
4 participants
|
1 participants
|
7 participants
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Progressive Disease (PD)
|
6 participants
|
9 participants
|
14 participants
|
0 participants
|
5 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of talazoparib. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=13 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=14 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=23 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=4 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=20 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=34 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
5.3 weeks
Interval 2.4 to 21.3
|
6.2 weeks
Interval 3.1 to 14.0
|
11.1 weeks
Interval 4.3 to 13.0
|
12.1 weeks
Interval 12.0 to
|
29.3 weeks
Interval 12.1 to 43.4
|
32.1 weeks
Interval 18.9 to 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)Population: Analysis performed on subset of response analysis population which included participants who had objective response. Data for outcome measure was planned to be analyzed combined for Part 1 and Part 2. "Overall number of participants analyzed" is zero (0) for arms of ewing, prostate, CLC cancer, since none of the participants had objective response.
Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=2 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=2 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=8 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=12 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response
|
NA weeks
Interval 21.6 to
Median and Upper limit of 95% CI were not estimable due to the less number of participants with events
|
—
|
13.6 weeks
Interval 12.0 to 15.3
|
—
|
32.2 weeks
Interval 20.1 to 64.1
|
26.9 weeks
Interval 15.7 to 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)Population: Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=13 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=14 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=23 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=1 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=20 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=31 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Stable Disease
|
2 participants
|
4 participants
|
4 participants
|
1 participants
|
7 participants
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 1 up to Day 42)Population: Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 or lower within 7 days), Grade 3 nausea, vomiting, or diarrhea that could be medically managed to grade 2 or lower with anti-emetics and/or anti-diarrheals within 24 hours, Grade 3 fatigue that improved to grade 2 or lower in 5 days or less, Alopecia. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=39 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Tolerated Dose (MTD)
|
—
|
—
|
—
|
—
|
1000 mcg/day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 50 (each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.
The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=39 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Recommended Part 2 Dose of Talazoparib
|
—
|
—
|
—
|
—
|
1000 mcg/day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Baseline up to 1071 days; Part 2: Baseline up to 834 daysPopulation: Safety analyses set included all enrolled participants who received at least 1 dose of talazoparib.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to 1071 days for Part 1 and up to 834 days for Part 2) that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
n=12 Participants
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=11 Participants
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
n=10 Participants
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
n=12 Participants
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
n=23 Participants
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
n=3 Participants
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
SAEs
|
2 participants
|
3 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
2 participants
|
5 participants
|
6 participants
|
4 participants
|
8 participants
|
0 participants
|
|
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
AEs
|
2 participants
|
3 participants
|
3 participants
|
6 participants
|
2 participants
|
3 participants
|
6 participants
|
6 participants
|
6 participants
|
12 participants
|
11 participants
|
10 participants
|
12 participants
|
21 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35Population: The pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 1 Day 1
|
214 picograms per milliliter (pg/mL)
Standard Deviation 50.9
|
788 picograms per milliliter (pg/mL)
Standard Deviation 369
|
1830 picograms per milliliter (pg/mL)
Standard Deviation 699
|
4100 picograms per milliliter (pg/mL)
Standard Deviation 1400
|
60.0 picograms per milliliter (pg/mL)
Standard Deviation 15.9
|
79.7 picograms per milliliter (pg/mL)
Standard Deviation 7.50
|
6100 picograms per milliliter (pg/mL)
Standard Deviation 3060
|
10600 picograms per milliliter (pg/mL)
Standard Deviation 4220
|
13200 picograms per milliliter (pg/mL)
Standard Deviation 3220
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 1 Day 35
|
1880 picograms per milliliter (pg/mL)
Standard Deviation 332
|
5620 picograms per milliliter (pg/mL)
Standard Deviation 3530
|
6560 picograms per milliliter (pg/mL)
Standard Deviation 1500
|
11300 picograms per milliliter (pg/mL)
Standard Deviation 3230
|
300 picograms per milliliter (pg/mL)
Standard Deviation 78.8
|
615 picograms per milliliter (pg/mL)
Standard Deviation 74.2
|
15400 picograms per milliliter (pg/mL)
Standard Deviation 1540
|
21000 picograms per milliliter (pg/mL)
Standard Deviation 7990
|
23400 picograms per milliliter (pg/mL)
Standard Deviation 4810
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=70 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
8480 pg/mL
Standard Deviation 3890
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
17700 pg/mL
Standard Deviation 5790
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 1 Day 1
|
1.02 hours
Interval 1.0 to 3.98
|
1.03 hours
Interval 1.0 to 2.32
|
2.03 hours
Interval 0.75 to 2.95
|
0.835 hours
Interval 0.75 to 1.95
|
7.92 hours
Interval 1.95 to 9.95
|
1.00 hours
Interval 0.8 to 1.02
|
2.00 hours
Interval 1.02 to 9.98
|
1.03 hours
Interval 0.73 to 2.07
|
1.00 hours
Interval 0.73 to 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 1 Day 35
|
0.785 hours
Interval 0.75 to 0.82
|
1.97 hours
Interval 1.0 to 3.02
|
0.980 hours
Interval 0.75 to 2.0
|
1.04 hours
Interval 0.73 to 5.98
|
1.02 hours
Interval 0.58 to 3.98
|
5.43 hours
Interval 0.77 to 10.1
|
1.02 hours
Interval 0.97 to 2.07
|
1.02 hours
Interval 0.75 to 2.0
|
1.48 hours
Interval 0.98 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=70 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
1.00 hours
Interval 0.5 to 4.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
1.07 hours
Interval 0.5 to 6.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
|
16600 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 5320
|
39300 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 11700
|
43700 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 15000
|
97900 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 30000
|
3600 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 1360
|
5340 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 1960
|
160000 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 66100
|
182000 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 62400
|
201000 picograms*hour per mililiter (pg*hr/mL)
Standard Deviation 93400
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=70 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
19100 pg*hr/mL
Standard Deviation 8850
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
50200 pg*hr/mL
Standard Deviation 16300
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 35Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Minimum Observed Plasma Concentration (Cmin) of Talazoparib
|
1020 pg/mL
Standard Deviation 107
|
2880 pg/mL
Standard Deviation 1710
|
2230 pg/mL
Standard Deviation 957
|
3470 pg/mL
Standard Deviation 1050
|
169 pg/mL
Standard Deviation 58.0
|
299 pg/mL
Standard Deviation 133
|
3180 pg/mL
Standard Deviation 802
|
3720 pg/mL
Standard Deviation 1590
|
2910 pg/mL
Standard Deviation 803
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of Talazoparib
|
37600 pg*hr/mL
Standard Deviation 6620
|
92700 pg*hr/mL
Standard Deviation 48500
|
60100 pg*hr/mL
Standard Deviation 15900
|
120000 pg*hr/mL
Standard Deviation 26000
|
5330 pg*hr/mL
Standard Deviation 1840
|
8320 pg*hr/mL
Standard Deviation 1960
|
188000 pg*hr/mL
Standard Deviation 85700
|
200000 pg*hr/mL
Standard Deviation 64000
|
235000 pg*hr/mL
Standard Deviation 111000
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
T1/2 is the time measured for the plasma concentration of talazoparib to decrease by one half.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Half-Life (t1/2) of Talazoparib
Cycle 1 Day 35
|
98.2 Hours
Standard Deviation 4.83
|
50.9 Hours
Standard Deviation 19.1
|
90.7 Hours
Standard Deviation 32.7
|
63.7 Hours
Standard Deviation 12.7
|
107 Hours
Standard Deviation 84.2
|
132 Hours
Standard Deviation 12.3
|
71.0 Hours
Standard Deviation 14.5
|
50.0 Hours
Standard Deviation 16.6
|
52.8 Hours
Standard Deviation 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Half-Life (t1/2) of Talazoparib
Cycle 1 Day 1
|
229 Hours
Standard Deviation 158
|
212 Hours
Standard Deviation 126
|
102 Hours
Standard Deviation 27.2
|
58.6 Hours
Standard Deviation 17.3
|
100 Hours
Standard Deviation 11.9
|
129 Hours
Standard Deviation 42.6
|
60.4 Hours
Standard Deviation 10.9
|
52.9 Hours
Standard Deviation 13.4
|
71.0 Hours
Standard Deviation 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/F) of Talazoparib
|
2.72 liter/hour
Standard Deviation 0.532
|
2.61 liter/hour
Standard Deviation 1.35
|
6.95 liter/hour
Standard Deviation 1.71
|
5.19 liter/hour
Standard Deviation 0.990
|
5.17 liter/hour
Standard Deviation 2.10
|
6.27 liter/hour
Standard Deviation 1.66
|
5.49 liter/hour
Standard Deviation 2.08
|
5.39 liter/hour
Standard Deviation 1.59
|
5.32 liter/hour
Standard Deviation 1.64
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35Population: The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed.
Outcome measures
| Measure |
Part 1: Talazoparib 100 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 Participants
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1 and Part 2: Talazoparib (Breast Cancer)
n=3 Participants
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=3 Participants
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
|
Part 1: Talazoparib (Colorectal Cancer)
n=6 Participants
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 Participants
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
|
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Volume of Distribution (Vz/F) of Talazoparib
Cycle 1 Day 35
|
475 liter
Standard Deviation 47.8
|
264 liter
Standard Deviation 249
|
818 liter
Standard Deviation 326
|
477 liter
Standard Deviation 136
|
1070 liter
Standard Deviation 971
|
1020 liter
Standard Deviation 345
|
604 liter
Standard Deviation 169
|
373 liter
Standard Deviation 144
|
472 liter
Standard Deviation 254
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Apparent Volume of Distribution (Vz/F) of Talazoparib
Cycle 1 Day 1
|
839 liter
Standard Deviation 487
|
678 liter
Standard Deviation 217
|
1050 liter
Standard Deviation 431
|
441 liter
Standard Deviation 143
|
756 liter
Standard Deviation 351
|
1240 liter
Standard Deviation 742
|
468 liter
Standard Deviation 169
|
415 liter
Standard Deviation 170
|
549 liter
Standard Deviation 232
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Talazoparib 25 mcg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Talazoparib 50 mcg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Talazoparib 100 mcg/Day
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Talazoparib 200 mcg/Day
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Talazoparib 400 mcg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Talazoparib 600 mcg/Day
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Talazoparib 900 mcg/Day
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Talazoparib 1000 mcg/Day
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Talazoparib 1100 mcg/Day
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2: Talazoparib (Breast Cancer)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2: Talazoparib (Pancreatic Cancer)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2: Talazoparib (Ewing Cancer)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2: Talazoparib (SCLC Cancer)
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Part 2: Talazoparib (Prostate Cancer)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Talazoparib 25 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 50 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 100 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 900 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
n=12 participants at risk
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=11 participants at risk
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
n=10 participants at risk
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
n=12 participants at risk
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
n=23 participants at risk
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Prostate Cancer)
n=3 participants at risk
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Community acquired infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Part 1: Talazoparib 25 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 50 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 100 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 200 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 400 mcg/Day
n=3 participants at risk
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 600 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 900 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1000 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 1: Talazoparib 1100 mcg/Day
n=6 participants at risk
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Breast Cancer)
n=12 participants at risk
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
n=11 participants at risk
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Pancreatic Cancer)
n=10 participants at risk
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Ewing Cancer)
n=12 participants at risk
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (SCLC Cancer)
n=23 participants at risk
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
Part 2: Talazoparib (Prostate Cancer)
n=3 participants at risk
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Bundle branch block left
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
5/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
90.9%
10/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
39.1%
9/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
5/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
6/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
81.8%
9/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
52.2%
12/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Local swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Medical device site reaction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Temperature intolerance
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Nodule
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Thirst
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Skin candida
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
4/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
45.5%
5/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
4/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
4/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
4/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Tooth extraction
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
5/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
3/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
34.8%
8/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
54.5%
6/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
34.8%
8/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Biopsy bone marrow
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
3/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hyperinflation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
54.5%
6/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
2/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hypotrichosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Breast reconstruction
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Frontal sinus operation
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
1/23 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
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